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LINK Instruments - Alignment and positioning instruments 35-1045/00

by WALDEMAR LINK GmbH & Co. KG GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04026575437672 UDI-DIDate15 Dec 2022ListedStatusListed 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  • Withdrawn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
LINK Instruments - Alignment and positioning instruments
Generic Name
Knee tibia prosthesis trial, reusable
Model / Reference
35-1045/00
Primary DI / UDI-DI
04026575437672
FDA Product Code
HWT
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class I
Regulation Number
888.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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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