FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867045962
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8737-01
Catalog number
AR-8737-01
Device description
GUIDE WIRE WITH TROCAR TIP, DIA 1.35MM
Published
2021-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867045962PrimaryGS10
00888867045965Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886704596210888867045962
00888867045965008888670459658888670459650888867045965

GMDN Terms#

Term, Definition table
TermDefinition
Suture/needle passer, single-useA sterile, hand-held, manual surgical instrument designed for passing (driving) sutures and suture needles through tissues/prosthetic materials to facilitate suturing (it is not dedicated to ophthalmic applications). A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867179493Arthrex®AR-8835L-08SAR-8835L-08S2017-04-07
00888867186293Arthrex®AR-8835-08SAR-8835-08S2017-03-03
00888867202733Arthrex®AR-8948W-2045AR-8948W-20452017-02-25
00888867237612Arthrex®AR-8827L-08SAR-8827L-08S2017-05-11
00888867238602Arthrex®AR-1927PSF-475AR-1927PSF-4752017-05-05
00888867483927Arthrex®AR-4020C-06DAR-4020C-06D2025-11-06
00888867525924Arthrex®AR-7269RAR-7269R2025-10-20
00888867456174Arthrex®AR-3610NDF-1AR-3610NDF-12025-11-14
00888867456181Arthrex®AR-3610NDF-2AR-3610NDF-22025-11-14
00888867456198Arthrex®AR-3610NDF-3AR-3610NDF-32025-11-14
00888867456204Arthrex®AR-3610NDF-4AR-3610NDF-42025-11-14
00888867525931Arthrex®AR-7269R-1AR-7269R-12025-10-20
00888867465220Arthrex®AR-1588SBR-RTAR-1588SBR-RT2025-06-23
00888867465237Arthrex®AR-1588SBR-RT-IBAR-1588SBR-RT-IB2025-06-23
00888867465244Arthrex®AR-1588SBR-RT-IBRAR-1588SBR-RT-IBR2025-06-23
00888867501324Arthrex®AR-1588SBR-RTT-IBAR-1588SBR-RTT-IB2025-06-23
00888867501331Arthrex®AR-1588SBR-RTT-IBRAR-1588SBR-RTT-IBR2025-06-23
00888867458048Arthrex®AR-S1000-C4AR-S1000-C42024-01-23
00888867426023Arthrex®AR-3711AR-37112023-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09