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Trewavis Surgical SBT100

by Trewavis Surgical Instruments Pty Ltd

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 Number09340254000632 UDI-DI Date20 Oct 2016ListedStatusListed 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  • Withdrawn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
Trewavis Surgical
Generic Name
Open-surgery biopsy forceps, reusable
Model / Ref / Catalog
SBT100, 100-010-00
Primary DI / UDI-DI
09340254000632
510(k) Number
FDA Product Code
FCK
GMDN Term
Open-surgery biopsy forceps, reusable
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Open-surgery biopsy forceps, reusable

Other devices from Trewavis Surgical Instruments Pty Ltd

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No