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Guide Wire 35304-160

by I.T.S. GmbH

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09120047309544 UDI-DI Date14 Nov 2018ListedStatusListed 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  • Withdrawn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
Guide Wire
Generic name
Orthopaedic guidewire, reusable
Model / Ref / Catalog
35304-160
Primary DI / UDI-DI
09120047309544
FDA product code
LXH
GMDN term
Orthopaedic guidewire, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic guidewire, reusable

Other devices from I.T.S. GmbH

See all devices from I.T.S. GmbH →

Properties

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

Other properties (11)

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