Quanta 1470 + 980

GUDID 08033945934262

QUANTA SYSTEM SPA

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system
Primary Device ID08033945934262
NIH Device Record Keye2d8aacb-9db1-4a9d-b984-94e0c275710a
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuanta 1470 + 980
Version Model NumberPDMS00216
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
GS108033945934262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2016-08-18

Devices Manufactured by QUANTA SYSTEM SPA

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
08059173395491 - Optical Fiber Reusable 10x2023-06-02 Reusable 10x optical fiber with 200 um diameter
08059173395521 - Optical Fiber Reusable 10x2023-06-02 Reusable 10x optical fiber with 272 um diameter

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