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Tecomet CR101007-AX

by Tecomet, Inc

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

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

Overview

A manual surgical instrument designed for cutting and excising bone tissue, typically during orthopaedic or plastic surgery procedures. This is a reusable device made of high-grade stainless steel, commonly used to remove bone without causing trauma.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818069017095 UDI-DI Date7 Oct 2020ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Bone curette, reusable
Model / reference
CR101007-AX
Primary DI / UDI-DI
00818069017095
FDA product code
HTF
GMDN term
Bone curette, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone curette, reusable

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)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No