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® - CMR45520 Catalog Number : CMR-4552

Device Description : Medium Malar Right

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CMR60520 Catalog Number : CMR-6052

Device Description : Large Malar Right

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH05540 Catalog Number : CSH-0554

Device Description : Sheet 0.45 x 50 x 40 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH05580 Catalog Number : CSH-0558

Device Description : Sheet 0.45 x 50 x 80 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH08540 Catalog Number : CSH-0854

Device Description : Sheet 0.80 x 50 x 40 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH08580 Catalog Number : CSH-0858

Device Description : Sheet 0.80 x 50 x 80 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH15540 Catalog Number : CSH-1554

Device Description : Sheet 1.5 x 50 x 40 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH15580 Catalog Number : CSH-1558

Device Description : Sheet 1.5 x 50 x 80 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH30540 Catalog Number : CSH-3054

Device Description : Sheet 3 x 50 x 40 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSH30580 Catalog Number : CSH-3058

Device Description : Sheet 3 x 50 x 80 mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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