BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Address:25155 Rye Canyon Loop,Valencia,CA,91355,US

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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

GENERATOR, LESION, RADIOFREQUENCY (GXD) (4) PROBE, RADIOFREQUENCY LESION (GXI) (4) Probe, radiofrequency lesion (GXI) (4) STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF (LGW) (1) Stimulator, spinal-cord, totally implanted for pain relief (LGW) (1)

Premarket Exempt

No Yes

Clear

NA - 00191506004873 Catalog Number :

Device Description : Clinician Programmer (Refurbished)

Device Class : 3

Duns Number: 824951958

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Bionic Navigator™ 3D - 00191506007546 Catalog Number :

Device Description : 4.1 Installer

Device Class : 3

Duns Number: 824951958

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

SideKick™ 2 - 00191506013097 Catalog Number :

Device Description : Siliconized 10cm x 10mm x 18ga (1.2mm)

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

SideKick™ 2 - 00191506013103 Catalog Number :

Device Description : Siliconized 10cm x 10mm x 20ga (0.9mm)

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

SideKick™ 2 - 00191506013110 Catalog Number :

Device Description : Siliconized 15cm x 10mm x 18ga (1.2mm)

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

SideKick™ 2 - 00191506013127 Catalog Number :

Device Description : Siliconized 15cm x 10mm x 20ga (0.9mm)

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

NA - 00813250010091 Catalog Number :

Device Description : CSK TC Electrode, 5cm

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXI, GXD

Prescription Use : Yes

Device Count : 1

NA - 00813250010107 Catalog Number :

Device Description : CSK TC Electrode, 10cm

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXI, GXD

Prescription Use : Yes

Device Count : 1

NA - 00813250010114 Catalog Number :

Device Description : CSK TC Electrode, 15cm

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXD, GXI

Prescription Use : Yes

Device Count : 1

NA - 00813250010138 Catalog Number :

Device Description : TEW Trigeminal Neuralgia Kit

Device Class : 2

Duns Number: 824951958

Premarket Exempt : No

Product Code : GXD, GXI

Prescription Use : Yes

Device Count : 1

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