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Orthopedic Instruments 5.5 Hex Wrench

by Gm Dos Reis Industria E Comercio Ltda GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07899258660998 UDI-DIDate20 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Orthopedic Instruments
Generic Name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
5.5 Hex Wrench, 353-109-1032
Primary DI / UDI-DI
07899258660998
FDA Product Code
LXH
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Gm Dos Reis Industria E Comercio Ltda

See all devices from Gm Dos Reis Industria E Comercio Ltda →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • 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