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Fujiyama 12011

by Fu Wah Medicine Co. Limited

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 Number35177850022011 UDI-DI Date16 Aug 2020ListedStatusListed 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  • Withdrawn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
Fujiyama
Generic Name
Surgical/medical face mask, single-use
Model / Ref / Catalog
12011, 2
Primary DI / UDI-DI
35177850022011
FDA Product Code
FXX
GMDN Term
Surgical/medical face mask, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution
Size
Balloon Length — 5.4 Inch

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Manufacturing Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No