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B.pure 64409552P

by Fourstar Group Inc.

B.pure 64409552P is a Class I device made by Fourstar Group Inc., listed in FDA GUDID since 3 Nov 2023 (UDI-DI 00049696898041), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00049696898041 UDI-DI Date3 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
B.pure
Generic name
Teething device, non-fluid-filled
Model / reference
64409552P
Primary DI / UDI-DI
00049696898041
FDA product code
MEF
GMDN term
Teething device, non-fluid-filled
Device class
Class I
Regulation number
872.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Teething device, non-fluid-filled

Other devices from Fourstar Group Inc.

See all devices from Fourstar Group Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)