BeamPath ROBOTIC fiber ROBOTIC

GUDID 00894338002818

Laser Fiber

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, single-use
Primary Device ID00894338002818
NIH Device Record Key1ddc5568-a910-47cd-a426-a6c02f39d4fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeamPath ROBOTIC fiber
Version Model NumberROBOTIC
Catalog NumberROBOTIC
Company DUNS030124221
Company NameOMNIGUIDE, INC.
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
GS100894338002818 [Primary]

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 Date2016-09-22

Devices Manufactured by OMNIGUIDE, INC.

00894338002672 - BeamPath NEURO-L Fiber2021-04-07 Laser Fiber
00894338002818 - BeamPath ROBOTIC fiber2021-04-07Laser Fiber
00894338002818 - BeamPath ROBOTIC fiber2021-04-07 Laser Fiber
00894338002825 - Elevate™ ENT Elite Fiber2021-04-07 Laser Fiber
00894338002849 - Omniguide Select Fiber2021-04-07 Laser Fiber
00894338002856 - Velocity™ High Performance Fiber2021-04-07 Laser Fiber
00852306007708 - TRIO Handpiece2019-06-14 The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact han
00852306007715 - Beacon Advanced Energy CO2 Laser System2019-06-06 A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber suppl
10894338002693 - Gas Filter Unit2018-07-06 Gas Filter Unit, Box of 10

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