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Compliance
| CERTIFICATES OF COMPLIANCE – DOT / IATA | ||
| Model Number(s) | ||
 |
Shipping System, Bexxar | 001-880 |
|
Shipping System, PET, Dose Pig, Single | 001-786 |
|
Shipping System, PET, Dose Pig, Double | 001-787 |
|
Shipping System, PET, Dose Pig, Triple | 001-739 |
|
Shipping System, PET, Double-Ended Pig | 001-794 |
|
Shipping System, PET, Vial | 001-724 |
|
Shipping System, Pro-Tec | 11 pieces of Biodex Pigs: 001-754, 001-280, 001-281, 001-282 |
|
Shipping System, Vial, Intego | 001-723 with Intego™ Tungsten Vial Pig |
|
Shipping System, Zevalin | 001-790 with Unit Dose Pigs 001-788 and 001-789 |
| TOP ^ | ||
| CERTIFICATES TO FOREIGN GOVERNMENT | ||
|
FDA Certificate to Foreign Government – Physical Medicine | |
|
FDA Certificate to Foreign Government – Radiology | |
| TOP ^ | ||
| DECLARATION OF CONFORMITY | ||
| Physical Medicine | Model Number(s) | |
|
Balance System SD | 950-440, 950-441, 950-444 |
|
BioStep 2 | 950-240, 950-244 |
|
BioSway | 950-460, 950-461 |
|
Gait Trainer 3 | 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408 |
|
Mobility Assist | 950-570 |
|
NxStep Unweighing System | 945-480, 950-485 |
|
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 |
|
System 4 Pro, Quick-Set and MVP | 850-000, 840-000, 852-000 |
|
System 4 Pro, Quick-Set and MVP Conformance to Standards | 850-000, 840-000, 852-000 |
|
System 4 Attachment, Dual Position Roll-Up Back | 830-450 |
|
System 4 Attachment, Closed Chain | 830-520 |
|
System 4 Component, Conversion Bundle | 850-830 |
|
System 4 Attachments, UE Hemiparetic | 830-540 |
|
Upper Body Cycle | 950-146, 950-148 |
| TOP ^ | ||
| Nuclear Medicine | Model Number(s) | ||
|
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 | ||
|
Atomlab 960 Thyroid Uptake System | 187-600, 187-601, 187-602 | |
|
Decontamination Kit | 121-180 | |
|
Injection Stand | 135-022 | |
|
L-Block Shields and Accessories | 042-413, 042-419, 042-428, 042-433,042-449, 042-417, 042-425, 042-426, 042-434, 042-435 | |
|
Lead Glass Goggles | 117-425 | |
|
Micro-Vent Kit, Disposable | 177-107 | |
|
Personnel Protective Shield, Mobile Barrier | ||
| Clear-Lead Mobile Nuclear Medicine Barrier | 042-585 | ||
| Clear-Lead Mobile X-Ray Barrier | 042-580, 042-582, 042-583 | ||
| Mobile Radiation Shield | 042-519, 042-522 | ||
|
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 | ||
|
PET Dose Drawing System | 001-855, 007-984, 007-986, 007-989, 042-426, 042-449, 042-455, 042-466, 042-467 | |
|
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 | ||
|
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 | ||
| Syringe Recapper | 008-300 | ||
|
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 | ||
| 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 | ||
| Z- PET | 007-945 | ||
|
Tabletop Shields and Accessories | 042-016, 017-810 | |
|
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 | ||
|
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 | ||
|
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 | ||
| TOP ^ | |||
| Medical Imaging | Model Number(s) | ||
|
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 | ||
|
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 | ||
|
MRI | ||
| Stretcher, MRI | 240-100 | ||
| Stretcher, MRI with Fowler Positioning | 240-110 | ||
| TOP ^ | |||
| D.O.T. PACKAGING TEST RECORD | ||
| Model Number(s) | ||
|
Shipping Container, Vial, Intego | 001-723 with 001-708 |
|
Shipping System, Bexxar | 001-880 |
|
Shipping System, Iodine-124 | 001-882 |
|
Shipping System, PET, Dose Pig, Single Unit | 001-786 |
|
Shipping System, PET, Dose Pig, Double Unit | 001-787 |
|
Shipping System, PET, Dose Pig, Triple Unit | 001-739 |
|
Shipping System, PET, Dose, Single or Multiple | 001-724 |
|
Shipping System, PET, Double Syringe with Needle | 001-751 |
|
Shipping System, PET, Double-Ended Pig | 001-794 |
|
Shipping System, Tech Nylon Bag | 001-754 |
| TOP ^ | ||
| EC CERTIFICATIONS | |||
|
EC Certificate Number 41312068-01 | ||
|
EC Certificate Number 41312458-01 | ||
|
EC Certificate Number 41313009-01 | ||
| TOP ^ | |||
| FDA COMPANY REGISTRATION | ||
 |
Establishment Registration & Device Listing | |
| TOP ^ | ||
| ISO CERTIFICATIONS | ||
|
ISO 13485 Certificate | |
|
ISO 9001 Certificate | |
| TOP ^ | ||
