Compliance

> Certificates of Compliance – DOT / IATA
> Certificates to Foreign Government
> Declarations of Conformity
 
> D.O.T Packaging Test Records
> EC Certifications
> FDA 2018 Company Registration
> ISO Certifications
> SDS, Safety Data Sheets

 

CERTIFICATES OF COMPLIANCE – DOT / IATA
  Model Number(s)
Download PDF Shipping System, Bexxar 001-880
Download PDF Shipping System, PET, Dose Pig, Single 001-786
Download PDF Shipping System, PET, Dose Pig, Double 001-787
Download PDF Shipping System, PET, Dose Pig, Triple 001-739
Download PDF Shipping System, PET, Double-Ended Pig 001-794
Download PDF Shipping System, PET, Vial 001-724
Download PDF Shipping System, Pro-Tec 11 pieces of Biodex Pigs: 001-754, 001-280, 001-281, 001-282
Download PDF Shipping System, Vial, Intego 001-723 with Intego™ Tungsten Vial Pig
Download PDF Shipping System, Zevalin 001-790 with Unit Dose Pigs 001-788 and 001-789

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CERTIFICATES TO FOREIGN GOVERNMENT
Download PDF FDA Certificate to Foreign Government – Physical Medicine
Download PDF FDA Certificate to Foreign Government – Radiology

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DECLARATION OF CONFORMITY
Physical Medicine Model Number(s)
Download PDF Balance System SD 950-440, 950-441, 950-444
Download PDF BioStep 2 950-240, 950-244
Download PDF BioSway 950-460, 950-461
Download PDF Gait Trainer 3 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408
Download PDF Mobility Assist 950-570
Download PDF NxStep Unweighing System 945-480, 950-485
Download PDF 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
Download PDF System 4 Pro, Quick-Set and MVP 850-000, 840-000, 852-000
Download PDF System 4 Attachment, Dual Position Roll-Up Back 830-450
Download PDF System 4 Attachment, Closed Chain 830-520
Download PDF System 4 Component, Conversion Bundle 850-830
Download PDF System 4 Attachments, UE Hemiparetic 830-540
Download PDF Upper Body Cycle 950-146, 950-148

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Nuclear Medicine Model Number(s)
Download PDF 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
Download PDF Atomlab 960 Thyroid Uptake System 187-600, 187-601, 187-602
Download PDF Decontamination Kit 121-180
Download PDF Injection Stand 135-022
Download PDF 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
Download PDF Lead Glass Goggles 117-425
Download PDF Micro-Vent Kit, Disposable 177-107
Download PDF 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
Download PDF 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
Download PDF PET Dose Drawing System 001-855, 007-984, 007-986, 007-989, 042-426, 042-449, 042-455, 042-466, 042-467
Download PDF 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
Download PDF 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
Download PDF 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
Download PDF Tabletop Shields and Accessories 042-016, 017-810
Download PDF 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
Download PDF 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
Download PDF 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)
Download PDF 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
Download PDF 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
Download PDF 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)
Download PDF Shipping Container, Vial, Intego 001-723 with 001-708
Download PDF Shipping System, Bexxar 001-880
Download PDF Shipping System, Iodine-124 001-882
Download PDF Shipping System, PET, Dose Pig, Single Unit 001-786
Download PDF Shipping System, PET, Dose Pig, Double Unit 001-787
Download PDF Shipping System, PET, Dose Pig, Triple Unit 001-739
Download PDF Shipping System, PET, Dose, Single or Multiple 001-724
Download PDF Shipping System, PET, Double Syringe with Needle 001-751
Download PDF Shipping System, PET, Double-Ended Pig 001-794
Download PDF Shipping System, Tech Nylon Bag 001-754

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EC CERTIFICATIONS
Download PDF EC Certificate Number 41312068
Download PDF EC Certificate Number 41312458
Download PDF EC Certificate Number 41313009

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FDA COMPANY REGISTRATION
Download PDF Establishment Registration & Device Listing

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ISO CERTIFICATIONS
Download PDF ISO 13485 Certificate
Download PDF ISO 9001 Certificate

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SDS, SAFETY DATA SHEETS
Download PDF MSDS, Battery in SuperWand Hand-Held Metal Detector  
Download PDF SDS, Belt Lubricant  
Download PDF SDS, Clear-Lead  
Download PDF SDS, Drierite Indicating  
Download PDF SDS, Drierite Non-Indicating  
Download PDF SDS, Lead Bricks  
Download PDF MSDS, Monolite Battery  
Download PDF SDS, Radiacwash  
Download PDF MSDS, Rad-Wipe Smear  
Download PDF SDS, Sodalime  
Download PDF SDS, Tec-Control Chromatography  

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