FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867395091
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-4403
Catalog number
ABS-4403
Device description
SPEEDFLEX 25 x 30 x 1mm Presutured Graft
Published
2025-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, nonabsorbable, synthetic, polyethylene
OWYMesh, surgical, collagen, orthopaedics, reinforcement of tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867395091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867395091008888673950918888673950910888867395091

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Expiration date on label
true

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
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
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