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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 ^ | ||
| CONFORMANCE TO STANDARDS | ||
|
Atomlab 500 Dose Calibrator | 086-330 |
|
Atomlab 960 (PC) Medical Spectrometer | 187-600, 187-601, 187-602 |
|
Balance System SD | 950-440, 950-441, 950-444, 950-450 |
|
Gait Trainer 3 | 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408 |
|
Pulmonex II Double-Trap Xenon System | 132-503 |
|
System 4 Pro, Quick-Set and MVP | 850-000, 840-000, 852-000 |
| TOP ^ | ||
| DECLARATION OF CONFORMITY | ||
|
Balance System SD | 950-430, 950-440, 950-441, 950-444, 950-450 |
|
Gait Trainer 3 | 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408, 950-413 |
|
NxStep Unweighing System | 945-480, 950-484, 950-485 |
|
System 4 Pro | 850-000 |
|
System 4 MVP | 852-000 |
|
System 4 Quick-Set | 840-000 |
|
System 4 Attachment, Dual Position Roll-Up Back | 830-450 |
|
System 4 Attachment, Closed Chain | 830-520 |
|
System 4 Attachments, Pediatric | 850-830 |
|
System 4 Attachments, UE Hemiparetic | 830-540 |
|
Atomlab 500, Wipe Test Counter and Accessories | |
| Atomlab 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 | |
|
C-Arm Tables | |
|
Table, Urology C-Arm – 800 |
058-800, 058-805 |
|
| 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, 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-Ended Pig | 001-794 |
|
Shipping System, Tech Nylon Bag | 001-754 |
|
Shipping System, Zevalin | 001-790 |
| 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 ^ | ||
| INTERNATIONAL DISTRIBUTOR AGREEMENT | ||
|
End User Statement | |
| TOP ^ | ||
| ISO CERTIFICATION | ||
|
ISO 13485 Certificate | |
| TOP ^ | ||
| SDS, SAFETY DATA SHEETS | ||
|
MSDS, Battery in SuperWand Hand-Held Metal Detector | 240-883, 240-884 |
|
SDS, Battery in Dosimeter Charger | 020-001 |
|
SDS, Battery in Monitor Survey Meter | 078-400 |
|
SDS, Battery in Ranger Survey Meter (AA) | 078-510 |
|
SDS, Battery in Ranger Survey Meter (Cell) | 078-510 |
|
SDS, Battery in Surface Survey Meter | 069-310 |
|
SDS, Treadmill Belt Lubricant | 945-276 |
|
SDS, Clear-Lead | -- |
|
SDS, Drierite Indicating | 132-772, 139-100, 139-104 |
|
SDS, Drierite Non-Indicating | 132-772, 139-100, 139-104 |
|
SDS, Lead Bricks | -- |
|
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 |
|
SDS, Radiacwash | 005-100, 005-155, 005-155, 005-301, 005-400 |
|
MSDS, Rad-Wipe Smear | 006-350 |
|
SDS, Sodalime | 130-019, 130-020, 132-773 |
|
SDS, Tec-Control Chromatography | 150-160 |
|
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 |
| TOP ^ | ||
