KELYNIAM GLOBAL, INC.

Address:97 RIVER RD STE A,COLLINSVILLE,CT,06019,US

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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

Plate, Cranioplasty, Preformed, Non-Alterable (GXN) (10)

Premarket Exempt

Clear

Kelyniam CSI - 00817580029006 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI012119-MM3

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029013 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI070621-AA1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029020 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI071421-DB1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029037 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI070621-EH1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029044 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI071621-RT1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029051 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI072221-AC1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029068 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI072221-RG1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029501 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, SmallCSI013020-MS1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029686 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI022820-SS1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580029709 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI031120-TM1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

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