NALU 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

Stimulator, Peripheral Nerve, Implanted (Pain Relief) (GZF) (10) Stimulator, Spinal-Cord, Implanted (Pain Relief) (GZB) (5)

Premarket Exempt

Clear

Nalu Medical, Inc. - 00812537030548 Catalog Number : 72002

Device Description : Lead Kit (8 contact, 60 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030555 Catalog Number : 72003-US

Device Description : Trial Lead Kit (8 contact, 60 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030562 Catalog Number : 72004-US

Device Description : Lead Extension Kit (8)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030579 Catalog Number : 74001-US

Device Description : Nalu Neurostimulation User's Kit

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030586 Catalog Number : 74002-US

Device Description : Nalu User's Trial Kit

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030630 Catalog Number : 12005-025

Device Description : Peripheral Nerve Stimulation Lead (4 contact, 25 cm, Tined)

Device Class :

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030715 Catalog Number : 34009-US

Device Description : Limb Cuff (Black)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030739 Catalog Number : 34011-US

Device Description : Limb Cuff, Large (Black)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030791 Catalog Number : 71006-US

Device Description : Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030807 Catalog Number : 71007-US

Device Description : Nalu Neurostimulation Kit (Ported, Single 4)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

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