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Pixie Cup B0GMTK2PST

by Pixie Cup, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850068130894 UDI-DI Date19 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Pixie Cup
Generic Name
Menstrual tampon, unscented
Model / Reference
B0GMTK2PST
Primary DI / UDI-DI
00850068130894
510(k) Number
FDA Product Code
HEB
GMDN Term
Menstrual tampon, unscented
Device Class
Class II
Regulation Number
884.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251033)

Show all (12)

Other devices from Pixie Cup, LLC

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Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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