BeamPath GYN-LAP Handpiece Set GYN-HS-LAP-1

GUDID 00852306007241

GYN Laparoscopic Handpiece Set, 2 Handpieces(GYN-LAP-33B and GYN-HP-46) & Tray(Handpiece Tray, GYN, LAP)

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, reusable
Primary Device ID00852306007241
NIH Device Record Keyd7854183-1ce8-4f6d-9fdc-2d99103b4823
Commercial Distribution StatusIn Commercial Distribution
Brand NameBeamPath GYN-LAP Handpiece Set
Version Model NumberGYN-HS-LAP-1
Catalog NumberGYN-HS-LAP-1
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
GS100852306007241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852306007241]

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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