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Depth Gauge W/ Countersink 110008459

by Biomet Orthopedics, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868463198 UDI-DI Date23 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0616-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Depth Gauge W/ Countersink
Generic Name
Surgical depth gauge, reusable
Model / Ref / Catalog
110008459
Primary DI / UDI-DI
00887868463198
510(k) Number
FDA Product Code
HWC
GMDN Term
Surgical depth gauge, reusable
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical depth gauge, reusable

Cleared under the same submission (K143188)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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