An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement,
| Company | Devices | Share |
|---|---|---|
| Davol Inc. | 92 | 30% |
| W. L. Gore & Associates, Inc. | 43 | 14% |
| Tepha, Inc. | 31 | 10% |
| Artelon | 25 | 8% |
| Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. | 20 | 6% |
| Gunze Limited | 16 | 5% |
| Synthasome, Inc. | 16 | 5% |
| Inion Oy | 13 | 4% |
| Mast Biosurgery Usa Inc. | 11 | 4% |
| Novus Scientific Ab | 8 | 3% |
| Nanofiber Solutions, Inc. | 7 | 2% |
| Ethicon Inc. | 7 | 2% |
Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 97 |
| OOD | surgical film | 92 |
| OOD | Surgical Film | 87 |
| FTL | Mesh, surgical, polymeric | 76 |
| OWT | Mesh, surgical, absorbable, abdominal hernia | 48 |
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of T | 37 |
Use these as the dimensions to specify in a tender line.
309 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable", from 18 companies. The largest labeler is Davol Inc. with 30% of records.
FTL (Mesh, Surgical, Polymeric), OOD (surgical film), OOD (Surgical Film), FTL (Mesh, surgical, polymeric)
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.