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B89104

by Black & Black Surgical Inc.

B89104 is a Class I device made by Black & Black Surgical Inc., listed in FDA GUDID since 21 Sep 2022 (UDI-DI 00840329811587), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840329811587 UDI-DI Date21 Sep 2022ListedStatusListed 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  • Withdrawn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

Generic name
Non-respiratory device ambient air filter
Model / Ref / Catalog
B89104
Primary DI / UDI-DI
00840329811587
FDA product code
GEA
GMDN term
Non-respiratory device ambient air filter
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Non-respiratory device ambient air filter

Similar devices

Other devices filed under FDA product code GEA (CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY).

Other devices from Black & Black Surgical Inc.

See all devices from Black & Black Surgical Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)