MEDTRONIC PS MEDICAL, INC.

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

PLATE, FIXATION, BONE (HRS) (6) Screw, fixation, bone (HWC) (2) Shunt, central nervous system and components (JXG) (2)

Premarket Exempt

No

Clear

TiMesh® - 00613994106827 Catalog Number :

Device Description : SCREW 9011635 TIMESH 1.6X3.5MM SDS OPT 1

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

TiMesh® - 00613994106834 Catalog Number :

Device Description : SCREW 9011640 TIMESH 1.6X4.0MM SDS OPT 1

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Strata® - 00613994128584 Catalog Number :

Device Description : SHUNT 27864 STRATA II REGULAR 120CM

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

NA - 00613994173560 Catalog Number :

Device Description : CATHETER 43555 PERITONEAL SMALL LUMEN

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

NA - 00613994284587 Catalog Number :

Device Description : MESH CMESH-3WK CUSTOM 3WK IMPLANT

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

NA - 00613994284594 Catalog Number :

Device Description : MESH CMESH-2WK CUSTOM 2WK IMPLANT

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

NA - 00613994284600 Catalog Number :

Device Description : MESH CMESH-1WK CUSTOM 1WK IMPLANT

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

TiMesh® - 00613994284617 Catalog Number :

Device Description : PANEL 016-100 CRANIAL MESH 100 X 100MM

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

TiMesh® - 00613994284624 Catalog Number :

Device Description : PANEL 016-120 CRANIAL MESH 120 X 120MM

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

TiMesh® - 00613994284631 Catalog Number :

Device Description : PANEL 016-128 CRANIAL MESH 128 X 79MM

Device Class : 2

Duns Number: 089055867

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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