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Toejack TJB-1000T-PKS

by Nvision Biomedical Technologies, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810135961288 UDI-DI Date29 Jul 2026ListedStatusListed 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  • Withdrawn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
Toejack
Generic name
Orthopaedic implantation sleeve, reusable
Model / reference
TJB-1000T-PKS
Primary DI / UDI-DI
00810135961288
FDA product code
LXH
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Nvision Biomedical Technologies, Inc

See all devices from Nvision Biomedical Technologies, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number

Other properties (11)

  • 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
  • Manufacturing date: No