A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different s
| Company | Devices | Share |
|---|---|---|
| Bentec Medical Opco, Llc | 73 | 52% |
| Technical Products Inc | 34 | 24% |
| Eon Meditech Private Limited | 17 | 12% |
| Medtronic Xomed, Inc. | 8 | 6% |
| Summit Medical, Inc. | 7 | 5% |
| Grace Medical, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 6 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 | 105 |
| MIB | ELASTOMER, SILICONE BLOCK | 33 |
| EPP | Splint, Nasal | 17 |
| KHJ | POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL) | 11 |
| MDA | Elastomer, Silicone, For Scar Management | 7 |
| NAD | Dressing, Wound, Occlusive | 2 |
Use these as the dimensions to specify in a tender line.
140 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Silicone-sheet tissue reconstructive material", from 6 companies. The largest labeler is Bentec Medical Opco, Llc with 52% of records.
FTL (Mesh, Surgical, Polymeric), MIB (ELASTOMER, SILICONE BLOCK), EPP (Splint, Nasal), KHJ (POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL))
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.