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Lighted Placement Tool 2850

by Bionix, LLC

Lighted Placement Tool 2850 is an earmould impression block insertion tool (FDA Class I; FDA product code JYG, Curette, Ear) made by Bionix, LLC, listed in FDA GUDID since 8 Aug 2022 (UDI-DI 00859911004726), 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 Number00859911004726 UDI-DI Date8 Aug 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  • Withdrawn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

Trade name
Lighted Placement Tool
Generic name
Earmould impression block insertion tool
Model / Ref / Catalog
2850
Primary DI / UDI-DI
00859911004726
FDA product code
JYG
GMDN term
Earmould impression block insertion tool
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Earmould impression block insertion tool

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)