OmniGuide® LapFlex Instrument Set 341003

GUDID 00852306007227

LapFlex Instrumentation Set (1 HandPiece & 1 Tray)

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, reusable
Primary Device ID00852306007227
NIH Device Record Keya947ab39-8366-46e7-a8f6-9507606d5941
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniGuide® LapFlex Instrument Set
Version Model Number341003
Catalog Number341003
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100852306007227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852306007227]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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00852306007708 - TRIO Handpiece2019-06-14 The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact han
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Trademark Results [OmniGuide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNIGUIDE
OMNIGUIDE
78636243 3134406 Live/Registered
OMNIGUIDE, INC.
2005-05-24
OMNIGUIDE
OMNIGUIDE
78636235 3134405 Live/Registered
OMNIGUIDE, INC.
2005-05-24
OMNIGUIDE
OMNIGUIDE
74634756 1942979 Dead/Cancelled
MICRO INTERVENTIONAL SYSTEMS, INC.
1995-02-16

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