OmniPore Surgical Implant Cutting Guide

GUDID 00852578008175

InvisiShunt Cutting Guide

MATRIX SURGICAL HOLDINGS, LLC

Polyethylene craniofacial tissue reconstructive material
Primary Device ID00852578008175
NIH Device Record Keyb7051039-3145-41f5-8f12-c885951fd346
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniPore Surgical Implant Cutting Guide
Version Model NumberOP5002
Company DUNS079634199
Company NameMATRIX SURGICAL HOLDINGS, LLC
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852578008175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00852578008175]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-24
Device Publish Date2020-04-16

On-Brand Devices [OmniPore Surgical Implant Cutting Guide ]

00855421005987InvisiShunt Cutting Guide
00852578008175InvisiShunt Cutting Guide
00852578008083InvisiShunt Cutting Guide
00852578008052InvisiShunt Cutting Guide
00852578008021InvisiShunt Cutting Guide

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