Nexgen Medical Systems, Inc.

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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

Catheter, Embolectomy (DXE) (3) Introducer, Catheter (DYB) (2)

Premarket Exempt

Clear

XCOIL Retractor - 00855975007024 Catalog Number :

Device Description : XCOIL Retractor - 12mm x 125cm (Short Eyelet)

Device Class : 2

Duns Number: 018652637

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

XCOIL Retractor - 00855975007031 Catalog Number :

Device Description : XCOIL Retractor - 12mm x 125cm (Long Eyelet)

Device Class : 2

Duns Number: 018652637

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

XCOIL Encapsulator - 00855975007048 Catalog Number :

Device Description : XCOIL Encapsulator - 11mm x 80cm

Device Class : 2

Duns Number: 018652637

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

XCOIL Encapsulator - 00855975007055 Catalog Number :

Device Description : Encapsulator 16mm x 70cm

Device Class : 2

Duns Number: 018652637

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

XCOIL Retractor - 00855975007062 Catalog Number :

Device Description : Retractor 18mm x 125cm

Device Class : 2

Duns Number: 018652637

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

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