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Silicone Block Size: 12.0cm x 7.0cm x 1.2cm

by Implantech Associates, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM724MHTBL12GM301 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Silicone Block
Generic Name
Silicone-block tissue reconstructive material
Model / Ref / Catalog
Size: 12.0cm x 7.0cm x 1.2cm, MHT-BL-1.2-GM-30
Primary DI / UDI-DI
M724MHTBL12GM301
510(k) Number
FDA Product Code
MIB
GMDN Term
Silicone-block tissue reconstructive material
Device Class
Class II
Regulation Number
874.3620
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K913882)

Show all (12)

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No