CEREMED, INC.

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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

Biopor® - CSR40520 Catalog Number : CSR-4052

Device Description : Medium Malar Shell R

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSR50520 Catalog Number : CSR-5052

Device Description : Large Malar Shell R

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UCR40640 Catalog Number : UCR-4064

Device Description : Small Round Chin

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UCR60640 Catalog Number : UCR-6064

Device Description : Medium Round Chin

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UCR90640 Catalog Number : UCR-9064

Device Description : Large Round Chin

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UCS40640 Catalog Number : UCS-4064

Device Description : Small Square Chin

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UCS60640 Catalog Number : UCS-6064

Device Description : Medium Square Chin

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UCS90640 Catalog Number : UCS-9064

Device Description : Large Square Chin

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UML30520 Catalog Number : UML-3052

Device Description : Small Malar Left

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - UML45520 Catalog Number : UML-4552

Device Description : Medium Malar Left

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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