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Device Explorer · FDA GUDID · GMDN 45230

Silicone-block tissue reconstructive material

A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-sect

US‑registered devices670in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile35%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Implantech Associates, Inc.47270%
Hanson Medical, Inc.8112%
Spectrum Designs Inc6610%
Surgical Technology Laboratories Inc162%
Bentec Medical Opco, Llc162%
International Medical Devices, Inc.152%
Technical Products Inc30%
Karl Storz Gmbh & Co. Kg10%

Top labelers

CompanyDevicesShare
Implantech Associates, Inc.47270%
Hanson Medical, Inc.8112%
Spectrum Designs Inc6610%
Surgical Technology Laboratories Inc162%
Bentec Medical Opco, Llc162%
International Medical Devices, Inc.152%
Technical Products Inc30%
Karl Storz Gmbh & Co. Kg10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

n.a.SurgiformSilicone BlockSilicone BlocksHimplant Pre-Formed Penile Silicone BlockTechnical ProductsCalf ImplantSilicone Carving BlockGluteal ImplantSpectrum Designs MedicalTemporal Shell Implant SizersTemporal Shell ImplantExtended Temporal Shell™ ImplantTemporal Shell™ ImplantSG Pec SizerSG Gluteal Sizer

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

FDA product codes

CodeNameDevices
MIBElastomer, Silicone Block677
MIBELASTOMER, SILICONE BLOCK198
MICImplant, Muscle, Pectoralis70
FWPProsthesis, Chin, Internal25
FTLMesh, Surgical, Polymeric13
LRCINSTRUMENT, ENT MANUAL SURGICAL1

GMDN & GCC registration

  • GMDN code 45230 · implantable
  • Single‑use 100% · sterile 35% · Rx‑only 98% · 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.

No closely related category with 50+ devices.

How many silicone-block tissue reconstructive material products are registered in the US?

670 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Silicone-block tissue reconstructive material", from 8 companies. The largest labeler is Implantech Associates, Inc. with 70% of records.

Which FDA product codes apply?

MIB (Elastomer, Silicone Block), MIB (ELASTOMER, SILICONE BLOCK), MIC (Implant, Muscle, Pectoralis), FWP (Prosthesis, Chin, Internal)

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.

How do I get quotes?

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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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