GYN Handpiece Mark III, 6 cm Bent GYN-HP-6B

GUDID 00852306007197

Handpiece, GYN, Mark III, 6 cm, Single Bend

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, reusable
Primary Device ID00852306007197
NIH Device Record Keyf6c1fbc0-0659-47f0-a0d8-4cd41aa6391c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYN Handpiece Mark III, 6 cm Bent
Version Model NumberGYN-HP-6B
Catalog NumberGYN-HP-6B
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
GS100852306007197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852306007197]

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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