Single Use CO2 Laser fiber

GUDID 08059173396580

QUANTA SYSTEM SPA

General/multiple surgical laser system beam guide, single-use
Primary Device ID08059173396580
NIH Device Record Keyb4773631-4be0-4255-a133-da23b8130459
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use CO2 Laser fiber
Version Model NumberHAF805001
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059173396573 [Primary]
GS108059173396580 [Package]
Contains: 08059173396573
Package: carton box [5 Units]
In Commercial Distribution
GS108059173396597 [Package]
Package: carto n box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-03
Device Publish Date2026-01-26

Devices Manufactured by QUANTA SYSTEM SPA

08059173396580 - Single Use CO2 Laser fiber2026-02-03
08059173396580 - Single Use CO2 Laser fiber2026-02-03
08059173396535 - Levanta Plus2025-12-05
08059173392186 - Litho EVO2025-10-07
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

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