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Bear 6.08.15

by Bear-Ent, LLC

Bear 6.08.15 is a Class I device made by Bear-Ent, LLC, listed in FDA GUDID since 18 Aug 2022 (UDI-DI G043608150), 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 NumberG043608150 UDI-DI Date18 Aug 2022ListedStatusListed GUDID: 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  • Withdrawn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
Bear
Generic name
Ear speculum, reusable
Model / Ref / Catalog
6.08.15
Primary DI / UDI-DI
G043608150
FDA product code
EPY
GMDN term
Ear speculum, reusable
Device class
Class I
Regulation number
878.1800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Ear speculum, reusable

Other devices from Bear-Ent, LLC

See all devices from Bear-Ent, LLC →

Properties

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