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Device Explorer · FDA GUDID · GMDN 61218

Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

A non-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].

US‑registered devices119in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Tei Biosciences Inc.8168%
Aroa Biosurgery Limited3630%
Integra Lifesciences Corporation22%

Top labelers

CompanyDevicesShare
Tei Biosciences Inc.8168%
Aroa Biosurgery Limited3630%
Integra Lifesciences Corporation22%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurgiMend®SurgiMend® PRSRevizeTM-XIntegra®TissueMend®OviTex® IHROviTex® LPROviTex® 2SOviTex® 1SOviTex® Core

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

FDA product codes

CodeNameDevices
FTMMesh, surgical81
FTMMesh, Surgical38
FTLMesh, Surgical, Polymeric36
OXHMesh, surgical, collagen, plastic and reconstructive surgery3

GMDN & GCC registration

  • GMDN code 61218 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 2Length (Centimeter) · 2

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

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

119 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, non-bioabsorbable", from 3 companies. The largest labeler is Tei Biosciences Inc. with 68% of records.

Which FDA product codes apply?

FTM (Mesh, surgical), FTM (Mesh, Surgical), FTL (Mesh, Surgical, Polymeric), 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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