Polyganics Innovations B.V.

Polyganics Innovations B.V.

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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

Cuff, Nerve (JXI) (8) Mesh, Surgical, Polymeric (FTL) (2)

Premarket Exempt

No

Clear

Neurolac - 08717703990133 Catalog Number : NG01-040/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

Neurolac - 08717703990140 Catalog Number : NG01-050/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

Neurolac - 08717703990157 Catalog Number : NG01-060/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

Neurolac - 08717703990164 Catalog Number : NG01-070/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

Neurolac - 08717703990171 Catalog Number : NG01-080/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

Neurolac - 08717703990188 Catalog Number : NG01-100/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : No

Device Count : 1

Vivosorb - 08717703990195 Catalog Number : FS01-006/20

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Vivosorb - 08717703990201 Catalog Number : FS01-035/20

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : FTL

Prescription Use : Yes

Device Count : 1

Vivosorb - 08717703990218 Catalog Number : FS01-130/20

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

NEUROCAP - 08717703990232 Catalog Number : NC01-015/03

Device Class : 2

Duns Number: 489946080

Premarket Exempt : No

Product Code : JXI

Prescription Use : Yes

Device Count : 1

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