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Affixus®full Anatomy Hex Driver Set Screw 2112-01-320

by Biomet Orthopedics, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868023309 UDI-DIDate23 May 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Affixus®full Anatomy Hex Driver Set Screw
Generic Name
Surgical screwdriver, reusable
Model / Ref / Catalog
2112-01-320, 211201320
Primary DI / UDI-DI
00887868023309
FDA Product Code
HWD
GMDN Term
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No