FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867301969
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-7292
Catalog number
AR-7292
Device description
SuturePatch Trapezoid, 45 x 35mm
Published
2025-06-13
Public version status
New
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
OWXMesh, surgical, non-absorbable, orthopaedics, reinforcement of tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888867301969PackageGS15In Commercial Distribution
00888867301962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886730196910888867301969
00888867301962008888673019628888673019620888867301962

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, bioabsorbableA bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.

Sterilization Methods#

Method table
Method

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
00888867050037Arthrex®AR-8933L-14SAR-8933L-14S2017-08-31
00888867050051Arthrex®AR-8933L-16SAR-8933L-16S2017-08-31
00888867050075Arthrex®AR-8933L-18SAR-8933L-18S2017-08-31
00888867051324Arthrex®AR-8940-16SAR-8940-16S2017-03-03
00888867051348Arthrex®AR-8940-18SAR-8940-18S2017-03-03
00888867051386Arthrex®AR-8940-22SAR-8940-22S2017-03-03
00888867051447Arthrex®AR-8940-28SAR-8940-28S2017-03-03
00888867051485Arthrex®AR-8940-32SAR-8940-32S2017-03-03
00888867051560Arthrex®AR-8940-40SAR-8940-40S2017-03-03
00888867051584Arthrex®AR-8940-42SAR-8940-42S2017-03-03
00888867053304Arthrex®AR-8945-22FTSAR-8945-22FTS2017-08-31
00888867053496Arthrex®AR-8945-30PTSAR-8945-30PTS2017-08-31
00888867053533Arthrex®AR-8945-32PTSAR-8945-32PTS2017-08-31
00888867053649Arthrex®AR-8945-36PTSAR-8945-36PTS2017-08-31
00888867053687Arthrex®AR-8945-38PTSAR-8945-38PTS2017-08-31
00888867053724Arthrex®AR-8945-40PTSAR-8945-40PTS2017-08-31
00888867053755Arthrex®AR-8945-45FTSAR-8945-45FTS2017-08-31
00888867053816Arthrex®AR-8945-50PTSAR-8945-50PTS2017-08-31
00888867053854Arthrex®AR-8945-55PTSAR-8945-55PTS2017-08-31
00888867053892Arthrex®AR-8945-60PTSAR-8945-60PTS2017-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810198920130TekBrace SoloTheraMicro, LLCOWX2026-04-17
00817337000418Integrity ImplantAnika Therapeutics, Inc.OWX2026-01-05
05060267134516FORCEWEB 5 mm x 500 mmXIROS LTDOWX2025-11-19
00817337000425Integrity ImplantAnika Therapeutics, Inc.OWX2025-09-19
00810198920055TekBrace SoloTheraMicro, LLCOWX2025-08-29
00810198920062TekBrace SoloTheraMicro, LLCOWX2025-08-29
05060267134271SIC GraftXIROS LTDOWX2025-08-07
05060267134493Infinity-Lock 3XIROS LTDOWX2025-08-07
05060267134509Infinity-Lock 5XIROS LTDOWX2025-08-07
00888867301931Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301962Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301986Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301948Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301955Arthrex®ARTHREX, INC.OWX2025-06-13
00888867301979Arthrex®ARTHREX, INC.OWX2025-06-13
10888867301983Arthrex®ARTHREX, INC.OWX2025-06-13
05060267134301AchilloCordPLUSXIROS LTDOWX2025-03-26
07649988202230FiberLocker ImplantZuriMED Technologies AGOWX2025-02-10
07649988202247FiberLocker InstrumentZuriMED Technologies AGOWX2025-02-10
05060267134295Poly-Tape 5 mm x 500 mmXIROS LTDOWX2024-10-10
00817337000241Integrity ImplantAnika Therapeutics, Inc.OWX2023-11-09
00817337000258Integrity Implant Anika Therapeutics, Inc.OWX2023-11-09
05060267133755Pitch-Patch 30 mm x 20 mmXIROS LTDOWX2023-10-05
05060267133762Pitch-Patch 35 mm x 25 mmXIROS LTDOWX2023-10-05
05060267131812Poly-Tape 30mm x 800mmXIROS LTDOWX2023-07-03
05060267132499Poly-Tape 5 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132505Poly-Tape 7 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132512Poly-Tape 10 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132529Poly-Tape 15 mm x 800 mm XIROS LTDOWX2022-10-14
05060267132536Poly-Tape 20 mm x 800 mm XIROS LTDOWX2022-10-14