Fiber Dust PRO

GUDID 08059173392292

QUANTA SYSTEM SPA

General/multiple surgical solid-state laser system
Primary Device ID08059173392292
NIH Device Record Key29266adb-58ff-4468-8bee-7a410dabd266
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiber Dust PRO
Version Model NumberPFMS00009
Company DUNS436045833
Company NameQUANTA SYSTEM SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059173392292 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-13
Device Publish Date2022-05-05

Devices Manufactured by QUANTA SYSTEM SPA

08059173396375 - Echo2024-07-01
08033945936938 - Laserlith I-dust 2024-05-23 Manufactured for Edap TMS
08059173396474 - Karma 2023-12-21
08059173396399 - Rosso2023-06-23
08059173396405 - Rosso2023-06-23
08033945934767 - Quantabella2023-06-16
08033945937492 - Litho 602023-06-16
08033945938369 - Litho 1002023-06-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.