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

ENDOSCOPE, NEUROLOGICAL (GWG) (3) CLIP, SCALP (HBO) (3) Shunt, central nervous system and components (JXG) (2) Screw, fixation, bone (HWC) (1) NYSTAGMOGRAPH (GWN) (1) DEVICE, MONITORING, INTRACRANIAL PRESSURE (GWM) (1) PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE (GXN) (1)

Premarket Exempt

Clear

TiMesh® - 20613994471561 Catalog Number :

Device Description : SCREW 8001850 RESCUE 1.8 X 5.0 6PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 6

Introducer Sheath - 20613994840312 Catalog Number :

Device Description : SHEATH 3805-012 PEELAWAY INTRO D12 5PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 5

Introducer Sheath - 20613994840329 Catalog Number :

Device Description : SHEATH 3805-014 PEELAWAY INTRO D14 5PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 5

Introducer Sheath - 20613994840336 Catalog Number :

Device Description : SHEATH 3805-015 PEELAWAY INTRO D15 5PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 5

Clip Gun - 20613994845058 Catalog Number :

Device Description : APPLICATOR CG8901A CLIP GUN RANEY 10 PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : HBO

Prescription Use : Yes

Device Count : 10

Clip Gun - 20643169109111 Catalog Number :

Device Description : KIT CG8901 CLIP GUN 10 PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : HBO

Prescription Use : Yes

Device Count : 10

Clip Gun - 20643169109135 Catalog Number :

Device Description : MAGAZINE CM8902 RANEY CLIP GUN 5PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : HBO

Prescription Use : Yes

Device Count : 5

ARES™ - 20643169288885 Catalog Number :

Device Description : CATHETER 95001 KIT ANTIMICROBIAL

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

N/A - 20643169466122 Catalog Number :

Device Description : KIT 46440 EDM LUMBAR DRAINAGE 5PK

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG, GWM, GWN

Prescription Use : Yes

Device Count : 5

INVISx® - 20643169466306 Catalog Number :

Device Description : LOCKS 60100 INVISX 2PK CE

Device Class :

Duns Number: 089055867

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 2

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