Skip to content

Sample, Lighted FlexLoop 22205

by Bionix, LLC

Sample, Lighted FlexLoop 22205, an ENT illuminating foreign body extraction set (FDA Class I; FDA product code JYG, Curette, Ear) made by Bionix, LLC, was listed in FDA GUDID on 10 Jul 2024 (UDI-DI 00714646000552); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00714646000552 UDI-DI Date10 Jul 2024ListedStatusListed GUDID: not 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  • Withdrawn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
Sample, Lighted FlexLoop
Generic name
ENT illuminating foreign body extraction set
Model / Ref / Catalog
22205
Primary DI / UDI-DI
00714646000552
FDA product code
JYG
GMDN term
ENT illuminating foreign body extraction set
Device class
Class I
Regulation number
874.4420
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code JYG (CURETTE, EAR).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

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