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Gauthier Biomedical G207165

by Gauthier Biomedical, Inc.

Gauthier Biomedical G207165 is a surgical instrument handle (FDA Class I; FDA product code LXH, Orthopedic Manual Surgical Instrument) made by Gauthier Biomedical, Inc., listed in FDA GUDID since 11 Aug 2020 (UDI-DI 00858325005312), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858325005312 UDI-DI Date11 Aug 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  • Withdrawn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
Gauthier Biomedical
Generic name
Surgical instrument handle, torque-limiting
Model / Ref / Catalog
G207165
Primary DI / UDI-DI
00858325005312
FDA product code
LXH
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 Gauthier Biomedical, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)