n.a. 2081211

by Karl Storz SE & CO. KG

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

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	Number04048551032879 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Ultrasonic lithotripsy system
Model / Reference: 2081211

Primary DI / UDI-DI: 04048551032879
FDA Product Code: FFK
GMDN Term: Ultrasonic lithotripsy system

Device Class: Class II
Regulation Number: 876.4480
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Other devices from Karl Storz SE & CO. KG

Karl Storz Supraloop

Class II
n.a. 791003DS

Class I
n.a. 268015

Class II
n.a. 744101

Class I
n.a. 28163ZSH

Class II
n.a. 11603ZS

Class II

See all devices from Karl Storz SE & CO. KG →

Properties

Prescription Use

Other properties (13)

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
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No