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 - 00817580020003 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, Medium

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020010 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, Small

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020027 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-Large

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020034 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, Small

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020041 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-Large

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020058 Catalog Number : PEEK-IM1003

Device Description : PEEK Customized Cranial Implant, Large

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020065 Catalog Number : PEEK-IM1003

Device Description : PEEK Customized Cranial Implant, Large

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020072 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, Small

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020089 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-Large

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580020096 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, Small

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

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