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TRACOE larynx REF 601-12

by Tracoe medical GmbH

Listed FDA GUDID listing, not in commercial distribution

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 Number04035324042715 UDI-DI Date14 Jan 2016ListedStatusListed GUDID: not 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  • Withdrawn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
TRACOE larynx
Generic Name
Tracheostoma button
Model / Ref / Catalog
REF 601-12
Primary DI / UDI-DI
04035324042715
FDA Product Code
KAC
GMDN Term
Tracheostoma button
Device Class
Class I
Regulation Number
874.4420
GUDID distribution status
Not in Commercial Distribution
Size
Lumen/Inner Diameter — 12.0 Millimeter

Other devices from Tracoe medical GmbH

See all devices from Tracoe medical GmbH →

Properties

  • Sterile
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No