Skip to content

Chemo Mouthpiece 100-0004

by Chemo Mouthpiece, LLC

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 Number10860001416715 UDI-DI Date22 May 2024ListedStatusListed 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  • Withdrawn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
Chemo Mouthpiece
Generic Name
Oral mucositis cryotherapy mouthpiece
Model / Reference
100-0004
Primary DI / UDI-DI
10860001416715
FDA Product Code
KYR
GMDN Term
Oral mucositis cryotherapy mouthpiece
Device Class
Class I
Regulation Number
880.6050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Oral mucositis cryotherapy mouthpiece

Other devices from Chemo Mouthpiece, LLC

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • 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
  • Serial Number: No
  • Manufacturing Date: No