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 - 00817580027439 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI071320-TO1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027446 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI071420-DB1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027453 Catalog Number : PEEK-IM1003

Device Description : PEEK Customized Cranial Implant, LargeCSI072120-CM1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027460 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI051220-RR1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027491 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI071620-AA1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027507 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI071620-RT1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027514 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI071620-EJ1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027521 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI092019-DP2

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027538 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI071720-LL1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027545 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI071620-LG1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

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