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Millennium 2-1685J16

by Avalign Technologies Inc.

Millennium 2-1685J16 is a Class I device made by Avalign Technologies Inc., listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00190776319052), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190776319052 UDI-DI Date23 Jun 2023ListedStatusListed 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  • Withdrawn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
Millennium
Generic name
Middle ear chisel
Model / reference
2-1685J16
Primary DI / UDI-DI
00190776319052
FDA product code
JYE
GMDN term
Middle ear chisel
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Middle ear chisel

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Properties

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