NALU MEDICAL, INC.

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) (10)

Premarket Exempt

No

Clear

Nalu Medical, Inc. - 00812537030043 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. - 00812537030050 Catalog Number : 12001-060-US

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. - 00812537030067 Catalog Number : 12002-030-US

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. - 00812537030074 Catalog Number : 12006-060-US

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. - 00812537030081 Catalog Number : 13001-US

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. - 00812537030098 Catalog Number : 23001-045-US

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. - 00812537030104 Catalog Number : 23001-060-US

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

Nalu Medical, Inc. - 00812537030111 Catalog Number : 23002-045-US

Device Description : Stylet (Bent, 45 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030128 Catalog Number : 23002-065-US

Device Description : Stylet (Bent, 65 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030135 Catalog Number : 23003-045-US

Device Description : Tearaway introducer assembly (10 cm sheath)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

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