OmniPore Customized Surgical Implant

GUDID 00855421005406

Customized Cranial Implant

MATRIX SURGICAL HOLDINGS, LLC

Polyethylene craniofacial tissue reconstructive material
Primary Device ID00855421005406
NIH Device Record Key39b22bdf-af31-4a9a-8cbc-e022c76ab098
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniPore Customized Surgical Implant
Version Model NumberOP89020
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
GS100855421005406 [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

[00855421005406]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

On-Brand Devices [OmniPore Customized Surgical Implant ]

00855421005420Contralateral Customized Facial Implant
00855421005413Customized Facial Implant
00855421005406Customized Cranial Implant

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