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01-8264

by Biomet Microfixation, Inc

01-8264 is a Class I device made by Biomet Microfixation, Inc, listed in FDA GUDID since 18 Apr 2017 (UDI-DI 00841036016296), 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 Number00841036016296 UDI-DI Date18 Apr 2017ListedStatusListed 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  • Withdrawn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

Generic name
ENT elevator
Model / Ref / Catalog
01-8264
Primary DI / UDI-DI
00841036016296
FDA product code
KAD
GMDN term
ENT elevator
Device class
Class I
Regulation number
874.4420
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: ENT elevator

Other devices from Biomet Microfixation, Inc

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Properties

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