FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867525924
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-7269R
Catalog number
AR-7269R
Device description
Radiopaque FTape Cerclage Suture, Gen 2
Published
2025-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, nonabsorbable, synthetic, polyethylene
JDQCerclage, fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
JDQCerclage, FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867525921PackageGS15In Commercial Distribution
00888867525924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886752592110888867525921
00888867525924008888675259248888675259240888867525924

GMDN Terms#

Term, Definition table
TermDefinition
Surgical support tape, non-bioabsorbableA band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.

Contacts#

Phone, Email table
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867576032Arthrex®AR-3636-REMPAR-3636-REMP2026-10-20
00888867576056Arthrex®AR-3641SP-REMPAR-3641SP-REMP2026-10-20
00888867576070Arthrex®AR-6573-1AR-6573-12026-10-20
00888867576087Arthrex®AR-6573-2AR-6573-22026-10-20
00888867568280Arthrex®AR-3210-0050-SJAR-3210-0050-SJ2026-10-16
00888867568297Arthrex®AR-3210-0051-SJAR-3210-0051-SJ2026-10-16
00888867568303Arthrex®AR-3210-0059-PKAR-3210-0059-PK2026-10-16
00888867568310Arthrex®AR-3210-0063-PKAR-3210-0063-PK2026-10-16
00888867568457Arthrex®AR-8650DS-NAR-8650DS-N2026-10-16
00888867427143Arthrex®AR-S6524-025-230CAR-S6524-025-230C2023-06-05
00888867389533Arthrex®AR-9928BCK-MISAR-9928BCK-MIS2023-05-22
00888867276086Arthrex®AR-9437-16AR-9437-162022-07-15
00888867060401Arthrex®AR-9439-16AR-9439-162018-06-02
00888867060418Arthrex®AR-9439-18AR-9439-182018-06-02
00888867060425Arthrex®AR-9441-16AR-9441-162018-06-14
00888867060432Arthrex®AR-9441-18AR-9441-182018-06-02
00888867060449Arthrex®AR-9443-16AR-9443-162018-06-14
00888867060456Arthrex®AR-9443-18AR-9443-182018-06-14
00888867060463Arthrex®AR-9445-17AR-9445-172018-06-28
00888867060470Arthrex®AR-9445-19AR-9445-192018-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810129094503InSet Subscap Repair KitThreadstone LLCGAT2026-10-16
20845854655501Argo KnotlessConmed CorporationGAT2026-09-25
20845854655518Argo KnotlessConmed CorporationGAT2026-09-25
14026704420305DEKNATELTELEFLEX INCORPORATEDGAT2026-09-21
07899258654799Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654805Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
07899258654812Stitch - Suture Wires and TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAGAT2026-08-27
00850051329038Sternalock EZJACE MEDICAL, LLCJDQ2023-05-26
14026704738028DEKNATELTELEFLEX INCORPORATEDGAT2021-08-03
34026704592242DEKNATELTELEFLEX INCORPORATEDGAT2021-01-22
14026704427021DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
34026704422228DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
34026704426073DEKNATELTELEFLEX INCORPORATEDGAT2020-12-18
14026704647825DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704647856DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670410DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670472DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670533DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670540DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704670601DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716286DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716293DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716316DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716330DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716347DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716354DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716408DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716422DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716453DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27
14026704716477DEKNATELTELEFLEX INCORPORATEDGAT2020-05-27