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Lithospec LS-6-A999b

by Medispec, Ltd.

Lithospec LS-6-A999b is a Class II device made by Medispec, Ltd., listed in FDA GUDID since 8 Jun 2023 (UDI-DI 07290016498455), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016498455 UDI-DI Date8 Jun 2023ListedStatusListed 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  • Withdrawn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
Lithospec
Generic name
Electromechanical lithotripsy system, intracorporeal
Model / reference
LS-6-A999b
Primary DI / UDI-DI
07290016498455
FDA product code
FFK
GMDN term
Electromechanical lithotripsy system, intracorporeal
Device class
Class II
Regulation number
876.4480
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Medispec, Ltd.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)