Single use Optical Fiber

GUDID 08033945933593

Single use Optical Fiber ø 200 µm

QUANTA SYSTEM SPA

Urogenital surgical laser system beam guide, single-use
Primary Device ID08033945933593
NIH Device Record Key982b624b-32eb-4d29-95b9-0d19bbff8499
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle use Optical Fiber
Version Model NumberOAF002001
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 Datefalse
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
GS108033945933593 [Primary]
GS108033945935184 [Package]
Package: carton [5 Units]
In Commercial Distribution
GS108033945935566 [Package]
Contains: 08033945935184
Package: carton [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2016-08-29

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