Compliance

>	Certificates of Compliance – DOT / IATA
>	Certificates to Foreign Government
>	Conformance to Standards
>	Declarations of Conformity
	Physical Medicine Products Nuclear Medicine Products Medical Imaging Products
>	D.O.T Packaging Test Records
>	EC Certifications
>	FDA 2018 Company Registration
>	International Distributor Agreement
>	ISO Certification
>	SDS, Safety Data Sheets

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

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

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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

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DECLARATION OF CONFORMITY
Physical Medicine		Model Number(s)
	Balance System SD	950-430, 950-440, 950-441, 950-444, 950-450
	BioStep 2	950-240
	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, 950-413
	Mobility Assist	950-570
	NxStep Unweighing System	945-480, 950-484, 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	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
	Upper Body Cycle	950-146, 950-148

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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
	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
	Decontamination Kit		121-180
	Injection Stand		135-022
	Lead Glass Goggles		117-425
	Micro-Vent Kit, Disposable		177-107
	Personnel Protective Shield, Mobile Barrier
		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
	Pulmonex II Xenon System		132-503
	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 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
	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

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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

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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

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EC CERTIFICATIONS
	EC Certificate Number 41312068-01
	EC Certificate Number 41312458-01
	EC Certificate Number 41313009-01

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FDA COMPANY REGISTRATION
	Establishment Registration & Device Listing

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INTERNATIONAL DISTRIBUTOR AGREEMENT
	End User Statement

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ISO CERTIFICATION
	ISO 13485 Certificate

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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

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