MATRIX SURGICAL HOLDINGS, LLC

MATRIX SURGICAL HOLDINGS, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (KKY) (9) Plate, Bone (JEY) (1)

Premarket Exempt

No

Clear

OmniPore Surgical Implant - 00852578008014 Catalog Number :

Device Description : InvisiShunt Implant

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant Cutting Guide - 00852578008021 Catalog Number :

Device Description : InvisiShunt Cutting Guide

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00852578008038 Catalog Number :

Device Description : InvisiShunt Kit (OP2001/OP2002)

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00852578008045 Catalog Number :

Device Description : InvisiShunt Implant

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant Cutting Guide - 00852578008052 Catalog Number :

Device Description : InvisiShunt Cutting Guide

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00852578008069 Catalog Number :

Device Description : InvisiShunt Implant Kit

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00852578008076 Catalog Number :

Device Description : OmniPore Surgical Implant

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant Cutting Guide - 00852578008083 Catalog Number :

Device Description : InvisiShunt Cutting Guide

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00852578008090 Catalog Number :

Device Description : InvisiShunt Kit (OP4001/OP4002)

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00852578008106 Catalog Number :

Device Description : DUROMAX® Orbital Implant - Small - 1.0mm

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : JEY

Prescription Use : No

Device Count : 1

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