FDA.report

Arthrex®

Primary DI
10888867020105
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1616-M
Catalog number
AR-1616-M
Device description
FINGER TRAP
Published
2018-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KQZCOMPONENT, TRACTION, NON-INVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888867020105PackageGS15In Commercial Distribution
00888867020108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886702010510888867020105
00888867020108008888670201088888670201080888867020108

GMDN Terms

TermDefinition
Orthopaedic casting standA structure/frame designed to hold and support a patient's torso or limb (arm or leg) in an appropriate position during an orthopaedic casting procedure. It typically consists of an adjustable base/pedestal and frame with a set of detachable components including limb-positioning attachments to maintain optimum joint alignment, supports for resting limbs, and blades for forming the cast. Typically the body part is placed on a blade and the cast material is wrapped around it; after completing the cast, the blade is removed from the cast to provide space for improved blood circulation and patient comfort. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16
00888867529069Arthrex®AR-8827H-16AR-8827H-162026-03-16
00888867529076Arthrex®AR-8827H-18AR-8827H-182026-03-16
00888867529083Arthrex®AR-8827H-20AR-8827H-202026-03-16
00888867529090Arthrex®AR-8827H-22AR-8827H-222026-03-16
00888867529106Arthrex®AR-8827H-24AR-8827H-242026-03-16
00888867529113Arthrex®AR-8827H-26AR-8827H-262026-03-16
00888867529120Arthrex®AR-8827H-28AR-8827H-282026-03-16
00888867529137Arthrex®AR-8827H-30AR-8827H-302026-03-16
00888867529144Arthrex®AR-8827H-32AR-8827H-322026-03-16

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00610570001712100 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
006105700017501500 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20
00610570006618BUCKS BOOT LGBird & Cronin, LLCKQZ2022-08-20
00610570006649BUCKS BOOT UNIV CLSD-COMPLETEBird & Cronin, LLCKQZ2022-08-20
00610570006656DISPOSABLE PAD-UNIVERSAL BOOTBird & Cronin, LLCKQZ2022-08-20
00610570006663SADDLE FOR UNIV BUCKS TRACTIONBird & Cronin, LLCKQZ2022-08-20
00610570011810DISKARD HEAD HALTERBird & Cronin, LLCKQZ2022-08-20
00610570011858DELUXE HEAD HALTER UNIV BLACKBird & Cronin, LLCKQZ2022-08-20
00610570012503SPREADER BAR 12" NOTCHEDBird & Cronin, LLCKQZ2022-08-20
0061057001260220# WATER WEIGHT BAGBird & Cronin, LLCKQZ2022-08-20
00610570068951EXERCISE BAND ANCHOR STRAPS 10/PKBird & Cronin, LLCKQZ2022-08-20
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