CEREMED, INC.

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

No

Clear

Biopor® - CCR40640 Catalog Number : CCR-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® - CCR60640 Catalog Number : CCR-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® - CCR90640 Catalog Number : CCR-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® - CCS40640 Catalog Number : CCS-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® - CCS60640 Catalog Number : CCS-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® - CCS90640 Catalog Number : CCS-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® - CML30520 Catalog Number : CML-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® - CML45520 Catalog Number : CML-4552

Device Description : Medium Malar Left

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CML60520 Catalog Number : CML-6052

Device Description : Large Malar Left

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CMR30520 Catalog Number : CMR-3052

Device Description : Small Malar Right

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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