FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867483286
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-2386-11HS
Catalog number
AR-2386-11HS
Device description
QuadPro Core, 11mm
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
10888867483283PackageGS15In Commercial Distribution
00888867483286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886748328310888867483283
00888867483286008888674832868888674832860888867483286

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867020498Arthrex®AR-1648AR-16482018-08-03
00888867319882Arthrex®AR-8980BCTAR-8980BCT2021-06-24
00888867501317Arthrex®AR-1588SBR-RTTAR-1588SBR-RTT2025-06-23
00888867328693Arthrex®AR-8933VCL-10SAR-8933VCL-10S2024-08-05
00888867328709Arthrex®AR-8933VCL-12SAR-8933VCL-12S2024-08-05
00888867328716Arthrex®AR-8933VCL-14SAR-8933VCL-14S2024-08-05
00888867328723Arthrex®AR-8933VCL-16SAR-8933VCL-16S2024-08-05
00888867328730Arthrex®AR-8933VCL-18SAR-8933VCL-18S2024-08-05
00888867328747Arthrex®AR-8933VCL-20SAR-8933VCL-20S2024-08-05
00888867328754Arthrex®AR-8933VCL-22SAR-8933VCL-22S2024-08-05
00888867328761Arthrex®AR-8933VCL-24SAR-8933VCL-24S2024-08-05
00888867328778Arthrex®AR-8933VCL-26SAR-8933VCL-26S2024-08-05
00888867328785Arthrex®AR-8933VCL-28SAR-8933VCL-28S2024-08-05
00888867328792Arthrex®AR-8933VCL-30SAR-8933VCL-30S2024-08-05
00888867328808Arthrex®AR-8933VCL-32SAR-8933VCL-32S2024-08-05
00888867328815Arthrex®AR-8933VCL-34SAR-8933VCL-34S2024-08-05
00888867328822Arthrex®AR-8933VCL-36SAR-8933VCL-36S2024-08-05
00888867328839Arthrex®AR-8933VCL-38SAR-8933VCL-38S2024-08-05
00888867328846Arthrex®AR-8933VCL-40SAR-8933VCL-40S2024-08-05
00888867328860Arthrex®AR-8933HVCL-12SAR-8933HVCL-12S2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21