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Calcusplit 27630020

by Karl Storz SE & CO. KG

Calcusplit 27630020 is a Class II device made by Karl Storz SE & CO. KG, listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04048551086087), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048551086087 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Calcusplit
Generic name
Electromechanical lithotripsy system, intracorporeal
Model / reference
27630020
Primary DI / UDI-DI
04048551086087
FDA product code
FFK
GMDN term
Electromechanical lithotripsy system, intracorporeal
Device class
Class II
Regulation number
876.4480
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electromechanical lithotripsy system, intracorporeal

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)