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) (8)

Premarket Exempt

Clear

Nalu Medical, Inc. - 10812537030330 Catalog Number : 34007-US

Device Description : Relief Belt (Black)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 10812537030712 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. - 10812537030736 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. - 10812537033775 Catalog Number : 12001-040

Device Description : Lead (8 contact, 40 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 10812537034550 Catalog Number : 12001-060

Device Description : Lead (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. - 10812537034598 Catalog Number : 12002-030

Device Description : Lead Extension (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. - 10812537034611 Catalog Number : 12006-060

Device Description : Trial Lead (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. - 10812537034635 Catalog Number : 13001

Device Description : Anchor

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 10812537034659 Catalog Number : 23001-045

Device Description : Spoonbill Needle (4.5"/11 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 10812537034673 Catalog Number : 23001-060

Device Description : Spoonbill Needle (6"/15 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

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