A non-sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy intended to be implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile).
| Company | Devices | Share |
|---|---|---|
| Technical Products Inc | 120 | 56% |
| Implantech Associates, Inc. | 83 | 39% |
| Exmoor Plastics Limited | 12 | 6% |
Company = labeler of record on GUDID. 3 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 | 109 |
| MIB | Elastomer, Silicone Block | 90 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 12 |
| HXA | Prosthesis, Tendon, Passive | 4 |
Use these as the dimensions to specify in a tender line.
215 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, non-sterile", from 3 companies. The largest labeler is Technical Products Inc with 56% of records.
FTL (Mesh, Surgical, Polymeric), MIB (Elastomer, Silicone Block), KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), HXA (Prosthesis, Tendon, Passive)
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.