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Bioseal Inc. 2104/25

by Bioseal, Inc.

Bioseal Inc. 2104/25 is a Class I device made by Bioseal, Inc., listed in FDA GUDID since 19 Dec 2023 (UDI-DI 00630094021041), 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 Number00630094021041 UDI-DI Date19 Dec 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  • Withdrawn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
Bioseal Inc.
Generic name
Gauze packer
Model / reference
2104/25
Primary DI / UDI-DI
00630094021041
FDA product code
GDY
GMDN term
Gauze packer
Device class
Class I
Regulation number
878.4450
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gauze packer

Other devices from Bioseal, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)