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Bear 6.15.01

by Bear-Ent, LLC

Bear 6.15.01 is a Class I device made by Bear-Ent, LLC, listed in FDA GUDID since 12 Jun 2022 (UDI-DI G043615010), 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 NumberG043615010 UDI-DI Date12 Jun 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  • Withdrawn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
Middle ear incus hook
Model / Ref / Catalog
6.15.01
Primary DI / UDI-DI
G043615010
FDA product code
JYL
GMDN term
Middle ear incus hook
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Incus hook

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)