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Device Explorer · FDA GUDID · GMDN 33473

PTFE/carbon-fibre craniofacial tissue reconstructive material

A sterile device that is made up of polytetrafluoroethylene (PTFE), commonly known as Teflon, reinforced with carbon fibres to make a porous implant material. Such a device may be used in cosmetic surgery to restore the shape of the chin, jaw, nose, or bones a

US‑registered devices124in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription43%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Shanghai Suokang Medical Implants Co.,Ltd.7157%
Surgical Technology Laboratories Inc3730%
Implantech Associates, Inc.1613%

Top labelers

CompanyDevicesShare
Shanghai Suokang Medical Implants Co.,Ltd.7157%
Surgical Technology Laboratories Inc3730%
Implantech Associates, Inc.1613%

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

Brand names on the register (sample)

TisuthesSFAM PledgetSFAMePTFE Sheet

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

FDA product codes

CodeNameDevices
FTLMesh, Surgical, Polymeric87
OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic 71
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxil37

GMDN & GCC registration

  • GMDN code 33473 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 43% · 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

No structured size data on the register.

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

How many ptfe/carbon-fibre craniofacial tissue reconstructive material products are registered in the US?

124 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "PTFE/carbon-fibre craniofacial tissue reconstructive material", from 3 companies. The largest labeler is Shanghai Suokang Medical Implants Co.,Ltd. with 57% of records.

Which FDA product codes apply?

FTL (Mesh, Surgical, Polymeric), OWR (Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic ), KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil)

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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