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Polysurge 1470 PDMS00191

by Quanta System SpA

Polysurge 1470 PDMS00191 is a Class II device made by Quanta System SpA, listed in FDA GUDID since 18 Aug 2016 (UDI-DI 08033945934323), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number08033945934323 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Polysurge 1470
Generic name
General/multiple surgical diode laser system
Model / reference
PDMS00191
Primary DI / UDI-DI
08033945934323
FDA product code
GEX
GMDN term
General/multiple surgical diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Quanta System SpA

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)