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® - CSL30520 Catalog Number : CSL-3052

Device Description : Small Malar Shell L

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSL40520 Catalog Number : CSL-4052

Device Description : Medium Malar Shell L

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSL50520 Catalog Number : CSL-5052

Device Description : Large Malar Shell L

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSP00160 Catalog Number : CSP-0016

Device Description : Orbiral Spheres - AOC Coated - ø16mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSP00180 Catalog Number : CSP-0018

Device Description : Orbiral Spheres - AOC Coated - ø18mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSP00190 Catalog Number : CSP-0019

Device Description : Orbiral Spheres - AOC Coated - ø19mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSP00200 Catalog Number : CSP-0020

Device Description : Orbiral Spheres - AOC Coated - ø20mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSP00210 Catalog Number : CSP-0021

Device Description : Orbiral Spheres - AOC Coated - ø21mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSP00220 Catalog Number : CSP-0022

Device Description : Orbiral Spheres - AOC Coated - ø22mm

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

Biopor® - CSR30520 Catalog Number : CSR-3052

Device Description : Small Malar Shell R

Device Class : 2

Duns Number: 626959824

Premarket Exempt : No

Product Code : KKY

Prescription Use : Yes

Device Count : 1

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