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 - 00817580028573 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI041620-MC1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028580 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI021220-MJ1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028597 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI021420-JG1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028603 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, SmallCSI020420-JA1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028610 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI022020-LP1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028627 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, SmallCSI022020-BL1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028634 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-Large & LargeCSI022620-GS1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028641 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI012220-TY1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028658 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI022720-MK1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028665 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI071919-SE2

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

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