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Device Explorer · FDA GUDID · GMDN 60907

Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

A 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]; som

US‑registered devices472in commercial distribution
Companies20labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Cook Biotech Incorporated14531%
Lifecell Corporation6814%
Aroa Biosurgery Limited4710%
Acell, Inc.398%
Tutogen Medical Gmbh286%
Dsm Biomedical, Inc.245%
Sofradim Production194%
Kerecis Hf.184%

Top labelers

CompanyDevicesShare
Cook Biotech Incorporated14531%
Lifecell Corporation6814%
Aroa Biosurgery Limited4710%
Acell, Inc.398%
Tutogen Medical Gmbh286%
Dsm Biomedical, Inc.245%
Sofradim Production194%
Kerecis Hf.184%
Davol Inc.184%
Tissue Regenix Wound Care Inc.123%
Conmed Corporation102%
Smith & Nephew, Inc.92%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Kerecis SurgiBind® Tendon ProtectKerecis® SurgiBind™SurgiPure® XDFortiva™ Porcine DermisTutopatch™ bovine pericardium 6x18 cmTutomesh™ bovine pericardium 13x22 cmTutomesh™ bovine pericardium10x16 cmTutopatch™ bovine pericardium 14x20 cmTutopatch™ bovine pericardium 12x16 cmTutopatch™ bovine pericardium 12x12 cmTutopatch™ bovine pericardium 10x16 cmTutopatch™ bovine pericardium10x12.5 cmTutopatch™ bovine pericardium 8x18 cmTutopatch™ bovine pericardium 8x16 cmTutopatch™ bovine pericardium 8x14 cmTutopatch™ bovine pericardium 8x11 cm

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FTMMesh, surgical276
FTMMesh, Surgical197
OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery81
OXHMesh, surgical, collagen, plastic and reconstructive surgery78
OXEMesh, Surgical, Collagen, Staple Line Reinforcement47
OWVMesh, surgical, collagen, diaphragmatic hernia44

GMDN & GCC registration

  • GMDN code 60907 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Centimeter) · 272Length (Centimeter) · 260Depth (Millimeter) · 33Depth (Centimeter) · 12Height (Centimeter) · 12Width (Millimeter) · 10

Use these as the dimensions to specify in a tender line.

How many extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial products are registered in the US?

472 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial", from 20 companies. The largest labeler is Cook Biotech Incorporated with 31% of records.

Which FDA product codes apply?

FTM (Mesh, surgical), FTM (Mesh, Surgical), OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery), OXH (Mesh, surgical, collagen, plastic and reconstructive surgery)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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