Litho 100

GUDID 08033945938369

QUANTA SYSTEM SPA

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system
Primary Device ID08033945938369
NIH Device Record Keyce63f143-cc11-4693-a3fb-824ec43d7802
Commercial Distribution StatusIn Commercial Distribution
Brand NameLitho 100
Version Model NumberPVMS00055
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
GS108033945938369 [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 Number3
Public Version Date2023-06-16
Device Publish Date2018-05-17

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
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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