Compliance

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

 

CERTIFICATES OF COMPLIANCE – DOT / IATA
  Model Number(s)
Download PDF [1] Shipping System, Bexxar [2] 001-880
Download PDF [3] Shipping System, PET, Dose Pig, Single [4] 001-786
Download PDF [5] Shipping System, PET, Dose Pig, Double [6] 001-787
Download PDF [7] Shipping System, PET, Dose Pig, Triple [8] 001-739
Download PDF [9] Shipping System, PET, Double-Ended Pig [10] 001-794
Download PDF [11] Shipping System, PET, Vial [12] 001-724
Download PDF [13] Shipping System, Pro-Tec [14] 11 pieces of Biodex Pigs: 001-754, 001-280, 001-281, 001-282
Download PDF [15] Shipping System, Vial, Intego [16] 001-723 with Intego™ Tungsten Vial Pig
Download PDF [17] Shipping System, Zevalin [18] 001-790 with Unit Dose Pigs 001-788 and 001-789

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CERTIFICATES TO FOREIGN GOVERNMENT
Download PDF [19] FDA Certificate to Foreign Government – Physical Medicine [20]
Download PDF [21] FDA Certificate to Foreign Government – Radiology [22]

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CONFORMANCE TO STANDARDS
Download PDF [23] Atomlab 960 (PC) Medical Spectrometer [23] [24] 187-600, 187-601, 187-602
Download PDF [25] Gait Trainer 3 [25] 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408
Download PDF [26] System 4 Pro, Quick-Set and MVP [26] 850-000, 840-000, 852-000

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DECLARATION OF CONFORMITY
Physical Medicine Model Number(s)
Download PDF [27] Balance System SD [27] 950-430, 950-440, 950-441, 950-444, 950-450
Download PDF [28] BioStep 2 [28] 950-240
Download PDF [29] BioSway [29] 950-460, 950-461
Download PDF [30] Gait Trainer 3 [30] 950-400, 950-401, 950-402, 950-403, 950-404, 950-405, 950-406, 950-407, 950-408, 950-413
Download PDF [31] Mobility Assist [31] 950-570
Download PDF [32] NxStep Unweighing System [32] 945-480, 950-484, 950-485
Download PDF [33] System 3 [33] 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 [34] System 4 Pro [34] 850-000
Download PDF [35] System 4 MVP [35] 852-000
Download PDF [36] System 4 Quick-Set [36] 840-000
Download PDF [37] System 4 Attachment, Dual Position Roll-Up Back [37] 830-450
Download PDF [38] System 4 Attachment, Closed Chain [38] 830-520
Download PDF [39] System 4 Attachments, Pediatric [39] 850-830
Download PDF [40] System 4 Attachments, UE Hemiparetic [40] 830-540
Download PDF [41] Upper Body Cycle [41] 950-146, 950-148

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Nuclear Medicine Model Number(s)
Download PDF [42] Atomlab 400, 500, Wipe Test Counter and Accessories [42]  
  [24]Atomlab 400, 500, and Wipe Test Counter 086-330, 086-331, 086-332, 086-335, 086-336
  Atomlab Dose Calibrator Accessories & Replacement Parts [24] 008-015, 075-596, 086-241, 086-242, 086-243, 086-338, 086-423, 086-435, 086-509
Download PDF [24] Atomlab 960 Thyroid Uptake System [24] 187-600, 187-601, 187-602
Download PDF [43] Clear Lead Mobile X-Ray Barrier [43]  
    Clear-Lead Mobile Nuclear Medicine Barrier 042-585
    Clear-Lead Mobile X-Ray Barrier 042-580, 042-582, 042-583
Download PDF [44] Decontamination Kit [44] 121-180
Download PDF [45] Injection Stand [45] 135-022
Download PDF [46] Lead Glass Goggles [46] 117-425
Download PDF [47] Micro-Vent Kit, Disposable [47] 177-107
Download PDF [48] Personnel Protective Shield, Mobile Barrier [48]  
    Mobile Radiation Shield 042-519, 042-522
Download PDF [49] Personnel Radiation Shields [49]  
    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 [50] PET Dose Drawing System [50] 001-855, 007-984, 007-986, 007-989, 042-426, 042-449, 042-455, 042-466, 042-467
Download PDF [51] Phantoms [51]  
    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 [52] Shielded Containers [52]  
    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
Download PDF [53] Syringe Shields [53]  
    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
Download PDF [54] Tabletop Shields and Accessories [54] 042-016, 017-810
Download PDF [55] Tec-Control Chromatography Kit and Accessories [55]  
    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 [56] Venti-Scan IV [56]  
    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 [57] Vial Shields [57]  
    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 [58] C-Arm Tables [58]  
    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 [59] Ultrasound Tables [59]  
    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 [60] MRI [60]  
    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 [61] Shipping Container, Vial, Intego [62] 001-723 with 001-708
Download PDF [63] Shipping System, Bexxar [64] 001-880
Download PDF [65] Shipping System, PET, Dose Pig, Single Unit [66] 001-786
Download PDF [67] Shipping System, PET, Dose Pig, Double Unit [68] 001-787
Download PDF [69] Shipping System, PET, Dose Pig, Triple Unit [70] 001-739
Download PDF [71] Shipping System, PET, Dose, Single or Multiple [72] 001-724
Download PDF [73] Shipping System, PET, Double-Ended Pig [74] 001-794
Download PDF [75] Shipping System, Tech Nylon Bag [76] 001-754
Download PDF [77] Shipping System, Zevalin [78] 001-790

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EC CERTIFICATIONS
Download PDF [79] EC Certificate Number 41312068-01 [79]
Download PDF [80] EC Certificate Number 41312458-01 [80]
Download PDF [81] EC Certificate Number 41313009-01 [81]

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FDA COMPANY REGISTRATION
Download PDF [82] Establishment Registration & Device Listing [82]

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ISO CERTIFICATION
Download PDF [83] ISO 13485 Certificate [84]

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SDS, SAFETY DATA SHEETS
Download PDF [85] MSDS, Battery in SuperWand Hand-Held Metal Detector [85] 240-883, 240-884
Download PDF [86] SDS, Battery in Dosimeter Charger [86] 020-001
Download PDF [87] SDS, Battery in Monitor Survey Meter [88] 078-400
Download PDF [89] SDS, Battery in Ranger Survey Meter (AA) [89] 078-510
Download PDF [90] SDS, Battery in Ranger Survey Meter (Cell) [90] 078-510
Download PDF [91] SDS, Battery in Surface Survey Meter [92] 069-310
Download PDF [93] SDS, Treadmill Belt Lubricant [94] 945-276
Download PDF [95] SDS, Clear-Lead [95] --
Download PDF [96] SDS, Drierite Indicating [96] 132-772, 139-100, 139-104
Download PDF [97] SDS, Drierite Non-Indicating [97] 132-772, 139-100, 139-104
Download PDF [98] SDS, Lead Bricks [98] --
Download PDF [99] MSDS, Monolite Battery [99] 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
Download PDF [87] SDS, Radiacwash [87] 005-100, 005-155, 005-155, 005-301, 005-400
Download PDF [100] MSDS, Rad-Wipe Smear [100] 006-350
Download PDF [101] SDS, Sodalime [101] 130-019, 130-020, 132-773
Download PDF [102] SDS, Tec-Control Chromatography [102] 150-160

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