FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867245112
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1650-08
Catalog number
AR-1650-08
Device description
EU Clamp, Shoulder Suspension System
Published
2019-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, skin pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867245112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867245112008888672451128888672451120888867245112

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic operating table topA component of a modular operating table designed as a detachable table top to support a patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted; it might be intended to provide traction, and may have x-ray transparent features. It is often intended to be used with additional patient positioners.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867543904Arthrex®AR-1101TH-13CT-SAR-1101TH-13CT-S2026-09-25
00888867543911Arthrex®AR-1101TH-8CT-SAR-1101TH-8CT-S2026-09-25
00888867543928Arthrex®AR-1101TH-13OT-SAR-1101TH-13OT-S2026-09-25
00888867543935Arthrex®AR-1101TH-8OT-SAR-1101TH-8OT-S2026-09-25
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867291690Arthrex®AR-3350-4031AR-3350-40312018-12-13
00888867291751Arthrex®AR-3355-4031AR-3355-40312018-12-13
00888867161085Arthrex®AR-3350-4071AR-3350-40712018-12-13
00888867161207Arthrex®AR-3355-4071AR-3355-40712018-12-13
00888867504059Arthrex®AR-9650CAR-9650C2026-09-21
00888867504066Arthrex®AR-9650C-01AR-9650C-012026-09-21
00888867504073Arthrex®AR-9650C-02AR-9650C-022026-09-21
00888867570764Arthrex®AR-9650SFL-10256AR-9650SFL-102562026-09-21
00888867570771Arthrex®AR-9650SFL-11250AR-9650SFL-112502026-09-21
00888867550292Arthrex®AR-6533S-STAR-6533S-ST2026-09-18
00888867550308Arthrex®AR-6533S-XLAR-6533S-XL2026-09-18
00888867550315Arthrex®AR-6534S-STAR-6534S-ST2026-09-18
00888867550322Arthrex®AR-6534S-XLAR-6534S-XL2026-09-18
00888867550339Arthrex®AR-6533S-STSAR-6533S-STS2026-09-18
00888867550346Arthrex®AR-6533S-XLSAR-6533S-XLS2026-09-18

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07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
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00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
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00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
00816299013337HoverMatt PROSWedgeHovertech InternationalFMP2026-07-06
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
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