GYN-LGT Handpiece Tray GYN-TRAY-LGT

GUDID 00852306007067

Handpiece Tray for GYN Lower Genital Handpiece Set (GYN-HS-LGT)

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, reusable
Primary Device ID00852306007067
NIH Device Record Key43d26f23-f3e9-4c15-b1a9-382502ad73b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYN-LGT Handpiece Tray
Version Model NumberGYN-TRAY-LGT
Catalog NumberGYN-TRAY-LGT
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 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
GS100852306007067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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