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) (10)

Premarket Exempt

Clear

OmniPore Surgical Implant - 00855421005123 Catalog Number :

Device Description : Orbital Sphere

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005130 Catalog Number :

Device Description : Orbital Sphere

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005147 Catalog Number :

Device Description : Orbital Sphere

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005154 Catalog Number :

Device Description : Orbital Sphere

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005161 Catalog Number :

Device Description : Orbital Sphere

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005239 Catalog Number :

Device Description : Nasal Sheet

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005246 Catalog Number :

Device Description : Two-Piece Chin - Small

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005253 Catalog Number :

Device Description : Two-Piece Chin - Medium

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005260 Catalog Number :

Device Description : Helical Rim - Right

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005277 Catalog Number :

Device Description : Helical Rim - Left

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

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