FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867051840
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8941KT
Catalog number
AR-8941KT
Device description
"THRDED G-WIRE,W/TRCR TIP,.062"""
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
10888867051840PrimaryGS10
00888867051843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886705184010888867051840
00888867051843008888670518438888670518430888867051843

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
00888867498105Arthrex®AR-3210-0037AR-3210-00372026-07-31
00888867532236Arthrex®AR-S7500-030-260-SAR-S7500-030-260-S2026-07-31
00888867532243Arthrex®AR-S7500-030-360-SAR-S7500-030-360-S2026-07-31
00888867532250Arthrex®AR-S7500-040-260-SAR-S7500-040-260-S2026-07-31
00888867532267Arthrex®AR-S7500-040-360-SAR-S7500-040-360-S2026-07-31
00888867532274Arthrex®AR-S7500-050-260-SAR-S7500-050-260-S2026-07-31
00888867544819Arthrex®AR-S7510-030-260AR-S7510-030-2602026-07-31
00888867544826Arthrex®AR-S7510-040-260AR-S7510-040-2602026-07-31
00888867544833Arthrex®AR-S7510-050-260AR-S7510-050-2602026-07-31
00888867544840Arthrex®AR-S7563-030-260AR-S7563-030-2602026-07-31
00888867544857Arthrex®AR-S7563-030-360AR-S7563-030-3602026-07-31
00888867544864Arthrex®AR-S7570-030-260AR-S7570-030-2602026-07-31
00888867544871Arthrex®AR-S7570-030-360AR-S7570-030-3602026-07-31
00888867544888Arthrex®AR-S7570-040-260AR-S7570-040-2602026-07-31
00888867544895Arthrex®AR-S7570-040-360AR-S7570-040-3602026-07-31
00888867572010Arthrex®AR-S7500-000-000WAR-S7500-000-000W2026-07-31
00888867572034Arthrex®AR-S7500-100-000WAR-S7500-100-000W2026-07-31
00888867572041Arthrex®AR-S7500-100-000FAR-S7500-100-000F2026-07-31
00888867571129Arthrex®ABS-1981-20SABS-1981-20S2026-07-29
00888867020498Arthrex®AR-1648AR-16482018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00888867532236Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532243Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532250Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532267Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532274Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544819Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544826Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31