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 - 00855421005284 Catalog Number :

Device Description : Ear Base Extended - Right

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005291 Catalog Number :

Device Description : Ear Base Extended - Left

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005307 Catalog Number :

Device Description : Block

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005314 Catalog Number :

Device Description : Block

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005321 Catalog Number :

Device Description : Block

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005338 Catalog Number :

Device Description : Block

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005345 Catalog Number :

Device Description : Block

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005352 Catalog Number :

Device Description : Block

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005383 Catalog Number :

Device Description : Sellar Buttress Implant (SBI™)

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

OmniPore Surgical Implant - 00855421005390 Catalog Number :

Device Description : Sellar Buttress Implant (SBI™) - Large

Device Class : 2

Duns Number: 079634199

Premarket Exempt : No

Product Code : KKY

Prescription Use : No

Device Count : 1

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