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CERTIFICATES OF COMPLIANCE – DOT / IATA | ||
Model Number(s) | ||
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Shipping System, Bexxar | 001-880 |
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Shipping System, PET, Dose Pig, Single | 001-786 |
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Shipping System, PET, Dose Pig, Double | 001-787 |
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Shipping System, PET, Dose Pig, Triple | 001-739 |
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Shipping System, PET, Double-Ended Pig | 001-794 |
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Shipping System, PET, Vial | 001-724 |
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Shipping System, Pro-Tec | 11 pieces of Biodex Pigs: 001-754, 001-280, 001-281, 001-282 |
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Shipping System, Vial, Intego | 001-723 with Intego™ Tungsten Vial Pig |
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Shipping System, Zevalin | 001-790 with Unit Dose Pigs 001-788 and 001-789 |
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CERTIFICATES TO FOREIGN GOVERNMENT | ||
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FDA Certificate to Foreign Government – Physical Medicine | |
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FDA Certificate to Foreign Government – Radiology | |
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CONFORMANCE TO STANDARDS | ||
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Atomlab 500 Dose Calibrator | 086-330 |
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Atomlab 960 (PC) Medical Spectrometer | 187-600, 187-601, 187-602 |
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Balance System SD | 950-440, 950-441, 950-444, 950-450 |
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Gait Trainer 3 | 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408 |
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Pulmonex II Double-Trap Xenon System | 132-503 |
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System 4 Pro, Quick-Set and MVP | 850-000, 840-000, 852-000 |
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DECLARATION OF CONFORMITY | ||
Physical Medicine | Model Number(s) | |
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Balance System SD | 950-430, 950-440, 950-441, 950-444, 950-450 |
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BioStep 2 | 950-240 |
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BioSway | 950-460, 950-461 |
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Gait Trainer 3 | 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408, 950-413 |
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Mobility Assist | 950-570 |
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NxStep Unweighing System | 945-480, 950-484, 950-485 |
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System 3 | 830-000, 830-002, 830-201, 830-202, 830-204, 830-205, 830-206, 830-207, 830-208 835-000, 835-002, 835-201, 835-202, 835-205, 835-206, 835-207, 835-208 |
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System 4 Pro | 850-000 |
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System 4 MVP | 852-000 |
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System 4 Quick-Set | 840-000 |
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System 4 Attachment, Dual Position Roll-Up Back | 830-450 |
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System 4 Attachment, Closed Chain | 830-520 |
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System 4 Attachments, Pediatric | 850-830 |
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System 4 Attachments, UE Hemiparetic | 830-540 |
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Upper Body Cycle | 950-146, 950-148 |
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Nuclear Medicine | Model Number(s) | ||
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Atomlab 400, 500, Wipe Test Counter and Accessories | ||
Atomlab 400, 500, and Wipe Test Counter | 086-330, 086-331, 086-332, 086-335, 086-336 | ||
Atomlab Dose Calibrator Accessories & Replacement Parts | 008-015, 075-596, 086-241, 086-242, 086-243, 086-338, 086-423, 086-435, 086-509 | ||
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Atomlab 960 Thyroid Uptake System | 187-600, 187-601, 187-602 | |
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Clear Lead Mobile X-Ray Barrier | ||
Clear-Lead Mobile Nuclear Medicine Barrier | 042-585 | ||
Clear-Lead Mobile X-Ray Barrier | 042-580, 042-582, 042-583 | ||
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Decontamination Kit | 121-180 | |
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Injection Stand | 135-022 | |
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Lead Glass Goggles | 117-425 | |
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Micro-Vent Kit, Disposable | 177-107 | |
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Personnel Protective Shield, Mobile Barrier | ||
Mobile Radiation Shield | 042-519, 042-522 | ||
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Personnel Radiation Shields | ||
Compact L-Block with Dose Calibrator Shield | 042-433 | ||
Deluxe L-Block Shield | 042-413 | ||
L-Block Shields | 042-419, 042-449 | ||
L-Block Caves & Accessories | 042-417, 042-425, 042-426, 042-434, 042-435 | ||
Tabletop Shield | 042-224, 042-710 | ||
Tabletop Shield Accessories | 042-226, 042-227, 042-228 | ||
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PET Dose Drawing System | 001-855, 007-984, 007-986, 007-989, 042-426, 042-449, 042-455, 042-466, 042-467 | |
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Phantoms | ||
Bar Phantoms | 243-800, 243-935, 243-955, 243-985, 243-986, 243-987 | ||
Flood Phantom | 043-054 | ||
Phantom Funnel | 131-010 | ||
Replacement Bottle | 043-361 | ||
Thyroid Neck Phantom | 043-365 | ||
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Pulmonex II Xenon System | 132-503 | |
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Shielded Containers | ||
Shielded Containers | 039-106, 039-110, 039-287, 039-288, 039-289, 050-200, 050-205, 050-250 | ||
Sharps Container Shield | 039-325, 039-326, 039-330, 039-335, 039-350, 039-412 | ||
Syringe Holder | 009-205 | ||
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Syringe Shields | ||
Beta | 007-956, 007-957 | ||
Dose Drawing | 007-661, 007-663, 007-665 007-691, 007-693, 007-695 | ||
Double-Ended PET Pig | 001-793 | ||
High Density Lead Glass | 007‐612, 007‐620, 007‐635, 007‐652 | ||
Pro-Tec II | 007-800, 007-801, 007-900, 007-901 | ||
Pro-Tec III | 007-723, 007-734, 007-735 007-736, 007-738, 007-755 | ||
Pro-Tec IV | 007-670, 007-675, 007-680, 007-685 | ||
PET | 007-973, 007-975, 007-980, 007-983, 007-985, 007-990, 007-995 | ||
PET Gaard Lock | 007-711, 007-712, 007-713 007-716, 007-717, 007-718 | ||
PET/MR | 007-961, 007-962, 007-966, 007-967 | ||
Replacement Glass | 007-974, 127-691, 127-693, 127-695, 127-700, 127-734, 127-735, 127-738, 127-789, 127-999 | ||
Syringe Carrier | 001-179, 001-180, 001-181, 001-182 | ||
Syringe Recapper | 008-300 | ||
Z- PET | 007-945 | ||
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Tabletop Shields and Accessories | 042-016, 017-810 | |
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Tec-Control Chromatography Kit and Accessories | ||
Kits | 150-780, 150-785 | ||
Solvents | 150-160, 150-773, 150-781, 150-783 | ||
Strips | 150-001, 150-005, 150-025, 150-122, 150-125 150-127, 150-130, 150-771, 150-772, 150-782 150-951, 150-952, 150-971, 150-991 | ||
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Venti-Scan IV | ||
Venti-Scan IV Convenience Kit | 177-091, 177-092 | ||
Venti-Scan IV Shield with IV Mount | 177-090 | ||
Venti Pak Adapter | 177-075 | ||
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Vial Shields | ||
Pig, Vial | 001-706, 001-855 | ||
Vial Shield, High Density Lead Glass | 001-075 | ||
VIal Shield, Tungsten, Magnetic Cap | 053-806, 053-806E | ||
VIal Shield, Tungsten | 053-805 | ||
Pig, Vial | |||
Vial Shield | 001-236 | ||
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Medical Imaging | Model Number(s) | ||
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C-Arm Tables | ||
Table, Urology C-Arm – 800 | 058-800, 058-805 | ||
Table, Brachytherapy C-Arm – 810 | 058-810, 058-815 | ||
Table, 3D Imaging C-Arm – 820 | 058-820, 058-825 | ||
Table, Surgical C-Arm – 840 | 058-840, 058-840-10, 058-845, 058-845-10 | ||
Table, Surgical C-Arm – 846 | 058-846, 058-846-10, 058-847, 058-847-10 | ||
Table, Pain Management C-Arm – 870 | 058-870, 058-870-10, 058-875, 058-875-10 | ||
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Ultrasound Tables | ||
Table, Combination, Sound Pro | 058-710, 058-715 | ||
Table, Echocardiography, Echo Pro | 058-700, 058-705 | ||
Table, Echocardiography, Econo | 058-701, 058-706 | ||
Table, Ultrasound, Econo | 058-726, 058-727 | ||
Table, Ultrasound, Ultra Pro | 058-720, 058-725 | ||
Table, Vascular Echocardiography, Echo/Vasc Pro | 058-702, 058-707 | ||
Table, Vascular Ultrasound, Vasc Pro | 058-732, 058-733 | ||
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MRI | ||
Stretcher, MRI | 240-100 | ||
Stretcher, MRI with Fowler Positioning | 240-110 | ||
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D.O.T. PACKAGING TEST RECORD | ||
Model Number(s) | ||
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Shipping Container, Vial, Intego | 001-723 with 001-708 |
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Shipping System, Bexxar | 001-880 |
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Shipping System, PET, Dose Pig, Single Unit | 001-786 |
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Shipping System, PET, Dose Pig, Double Unit | 001-787 |
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Shipping System, PET, Dose Pig, Triple Unit | 001-739 |
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Shipping System, PET, Dose, Single or Multiple | 001-724 |
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Shipping System, PET, Double-Ended Pig | 001-794 |
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Shipping System, Tech Nylon Bag | 001-754 |
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Shipping System, Zevalin | 001-790 |
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EC CERTIFICATIONS | |||
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EC Certificate Number 41312068-01 | ||
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EC Certificate Number 41312458-01 | ||
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EC Certificate Number 41313009-01 | ||
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FDA COMPANY REGISTRATION | ||
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Establishment Registration & Device Listing | |
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INTERNATIONAL DISTRIBUTOR AGREEMENT | ||
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End User Statement | |
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ISO CERTIFICATION | ||
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ISO 13485 Certificate | |
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SDS, SAFETY DATA SHEETS | ||
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MSDS, Battery in SuperWand Hand-Held Metal Detector | 240-883, 240-884 |
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SDS, Battery in Dosimeter Charger | 020-001 |
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SDS, Battery in Monitor Survey Meter | 078-400 |
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SDS, Battery in Ranger Survey Meter (AA) | 078-510 |
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SDS, Battery in Ranger Survey Meter (Cell) | 078-510 |
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SDS, Battery in Surface Survey Meter | 069-310 |
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SDS, Treadmill Belt Lubricant | 945-276 |
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SDS, Clear-Lead | -- |
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SDS, Drierite Indicating | 132-772, 139-100, 139-104 |
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SDS, Drierite Non-Indicating | 132-772, 139-100, 139-104 |
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SDS, Lead Bricks | -- |
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MSDS, Monolite Battery | 056-862, 056-863, 058-800, 058-805, 058-810, 058-815, 058-820, 058-825, 058-840, 058-840-10, 058-845, 058-845-10, 058-878, 058-879, 945-480, 950-485 |
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SDS, Radiacwash | 005-100, 005-155, 005-155, 005-301, 005-400 |
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MSDS, Rad-Wipe Smear | 006-350 |
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SDS, Sodalime | 130-019, 130-020, 132-773 |
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SDS, Tec-Control Chromatography | 150-160 |
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SDS, Tungsten | 007-723, 007-734, 007-755, 007-735, 007-736, 007-738, 007-755, 007-800, 007-801, 007-900, 007-901, 053-806, 053-807 |
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