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Tecomet TM163080-BH

by Tecomet, Inc

Tecomet TM163080-BH is a surgical instrument handle (FDA Class I; FDA product code HXX, Screwdriver) made by Tecomet, Inc, listed in FDA GUDID since 15 Oct 2020 (UDI-DI 00841435107700), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841435107700 UDI-DI Date15 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Tecomet
Generic name
Surgical instrument handle, torque-limiting
Model / reference
TM163080-BH
Primary DI / UDI-DI
00841435107700
FDA product code
HXX
GMDN term
Surgical instrument handle, torque-limiting
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, torque-limiting

Similar devices in this category

Other devices filed under Surgical instrument handle, torque-limiting.

Other devices from Tecomet, Inc

See all devices from Tecomet, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)