FDA.report

Arthrex®

Primary DI
00888867048874
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8913DS
Catalog number
AR-8913DS
Device description
MINI TIGHTROPE IMPLANT WITH INSERTER
Published
2017-02-15
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
HTNWASHER, BOLT NUT

Product Code Classifications

CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867048874PrimaryGS10
M150AR8913DS1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867048874008888670488748888670488740888867048874

GMDN Terms

TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use 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
false
HCT/P
false
Kit
true
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

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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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888867529045Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529052Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529106Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529120Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529168Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529199Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529205Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529229Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529236Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529243Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529281Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529328Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529335Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529410Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529427Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529472Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529519Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529540Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529557Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529588Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529601Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530072Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530096Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530195Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531895Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531949Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531970Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531987Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532014Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532038Arthrex®ARTHREX, INC.HTN2026-03-16