Single use Side-firing Surgical Fiber

GUDID 08033945935870

Single use Ø 600 µm Sterile Side-firing Surgical Fiber

QUANTA SYSTEM SPA

Urogenital surgical laser system beam guide, single-use
Primary Device ID08033945935870
NIH Device Record Key890454c6-8dd6-44d1-b81b-9b8b5ed5bc7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle use Side-firing Surgical Fiber
Version Model NumberOBM001239
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
GS108033945934507 [Primary]
GS108033945935870 [Package]
Contains: 08033945934507
Package: CARTON [5 Units]
In Commercial Distribution

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 Number3
Public Version Date2021-04-07
Device Publish Date2016-09-02

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