MEDTRONIC PS MEDICAL, 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

Shunt, central nervous system and components (JXG) (10) DEVICE, MONITORING, INTRACRANIAL PRESSURE (GWM) (7) External cerebrospinal fluid (CSF) diversion (PCB) (3)

Premarket Exempt

Clear

Duet® - 00613994430526 Catalog Number :

Device Description : BAG 46911 DRAINAGE DEHP-FREE 1PK

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

Duet® - 00613994445360 Catalog Number :

Device Description : EDMS 46913 DUET INTERLINK SITES

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

Duet® - 00613994445377 Catalog Number :

Device Description : EDMS 46914 DUET BLUECORE SITES

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

Duet® - 00613994445384 Catalog Number :

Device Description : EDMS 46915 DUET INTERLINK WITH VCATH

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWM, PCB, JXG

Prescription Use : Yes

Device Count : 1

Duet® - 00613994445391 Catalog Number :

Device Description : EDMS 46916 DUET BLUECORE WITH VCATH

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : PCB, JXG, GWM

Prescription Use : Yes

Device Count : 1

Duet® - 00613994445407 Catalog Number :

Device Description : EDMS 46917 DUET INTERLINK WITH LCATH

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWM, JXG, PCB

Prescription Use : Yes

Device Count : 1

Clear-Site® - 00613994450661 Catalog Number :

Device Description : EDMS 46918 CLEAR-SITE LASER LEVEL

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG, GWM

Prescription Use : Yes

Device Count : 1

Rivulet™ - 00613994480446 Catalog Number :

Device Description : CATHETER 41701 RIVULET VENTRICULAR

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

NA - 00613994505217 Catalog Number :

Device Description : KIT 11-0401-CE SEPS OUS

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Strata® - 00613994556554 Catalog Number :

Device Description : ASSY 27903 STRATA II SM CP CATHETER

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

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