N/A Cs 3830-02

by Ulrich GmbH & Co. KG

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04052536081288 UDI-DI	Date30 Jul 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-1126-2019 FDA Class II initiated 8 Mar 2019 on shared 510(k) K123717
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog: CS 3830-02

Primary DI / UDI-DI: 04052536081288
510(k) Number: K123717
FDA Product Code: MNH, MNI, NKB
GMDN Term: General internal orthopaedic fixation system implantation kit

Device Class: Class II
Regulation Number: 888.3070
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