OmniPore Surgical Implant

GUDID 00855421005277

Helical Rim - Left

MATRIX SURGICAL HOLDINGS, LLC

External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable External ear prosthesis, implantable
Primary Device ID00855421005277
NIH Device Record Keyc3f7715f-6364-4b57-a2da-4d99839c4ff9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniPore Surgical Implant
Version Model NumberOP8329
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
GS100855421005277 [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

[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


[00855421005277]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-22
Device Publish Date2020-04-21

On-Brand Devices [OmniPore Surgical Implant]

90852578008000InvisiShunt Kit (OP1001/OP1002)
00855421005970OmniPore Surgical Implant
00852578008182InvisiShunt Kit (OP5001/OP5002)
00852578008168InvisiShunt Implant
00852578008090InvisiShunt Kit (OP4001/OP4002)
00852578008076OmniPore Surgical Implant
00852578008069InvisiShunt Implant Kit
00852578008045InvisiShunt Implant
00852578008038InvisiShunt Kit (OP2001/OP2002)
00852578008014InvisiShunt Implant
00855421005963Burr Hole Cover
00855421005956Burr Hole Cover
00855421005826Bendblock Implant
00855421005352Block
00855421005345Block
00855421005338Block
00855421005321Block
00855421005314Block
00855421005307Block
00855421005161Orbital Sphere
00855421005154Orbital Sphere
00855421005147Orbital Sphere
00855421005130Orbital Sphere
00855421005123Orbital Sphere
00855421005048Sheet
00855421005031Sheet
00855421005024Ultra Thin Sheet
00855421005000Ultra Thin Sheet
00855421005840Design Y™ Inferior Orbital Rim - Right
00855421005833Design Y™ Inferior Orbital Rim - Left
00855421005574Design Y™ Malar - Small -Left
00855421005567Design Y™ Malar - Small - Right
00855421005949CHANNEL Sheet
00855421005895Large Paranasal - Right
00855421005888Large Paranasal - Left
00855421005871Petite Paranasal - Right
00855421005864Petite Paranasal - Left
00855421005857Extended Orbital Rim - Left
00855421005819BENDBLOCK™ TF2 Large - Right
00855421005802BENDBLOCK™ TF2 Large - Left
00855421005796BENDBLOCK™ TF2 Medium - Right
00855421005789BENDBLOCK™ TF2 Medium - Left
00855421005772BENDBLOCK™ TF2 Small - Right
00855421005765BENDBLOCK™ TF2 Small - Left
00855421005758BENDBLOCK™ Cranial Grid Implant
00855421005741Cranial Hemisphere - Left
00855421005734Cranial Hemisphere - Right
00855421005635Pterional Implant - Left
00855421005628Pterional Implant - Right
00855421005611Design Y™ Malar - Large - Left

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