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Sample, Lighted Placement Tool SP-22850

by Bionix, LLC

Sample, Lighted Placement Tool SP-22850 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 27 Oct 2022 (UDI-DI 00714646001030), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00714646001030 UDI-DI Date27 Oct 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  • Withdrawn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
Sample, Lighted Placement Tool
Generic name
Earmould impression block insertion tool
Model / Ref / Catalog
SP-22850, 22850
Primary DI / UDI-DI
00714646001030
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

Also classified as 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)