Instrument Case 5967-01

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024212626 UDI-DI	Date5 Oct 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-0630-2019 FDA Class II initiated 31 Oct 2018
Screw is missing from the package

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Instrument Case
Generic Name: Device sterilization/disinfection container, reusable
Model / Ref / Catalog: 5967-01, 00-5967-001-00

Primary DI / UDI-DI: 00889024212626
510(k) Number: K152494
FDA Product Code: KRO, JWH
GMDN Term: Device sterilization/disinfection container, reusable

Device Class: Class II
Regulation Number: 888.3510, 888.3560
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number
Manufacturing Date

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
Premarket Exempt: No
Serial Number: No
Expiration Date: No