Laserclast TM Fiber PFMS00007

GUDID 08059173392285

QUANTA SYSTEM SPA

General/multiple surgical solid-state laser system
Primary Device ID08059173392285
NIH Device Record Keyfe137c9a-386b-4020-9bf9-18af5036bd6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaserclast TM Fiber
Version Model NumberFT-248
Catalog NumberPFMS00007
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
GS108059173392285 [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

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