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. - 00812537030142 Catalog Number : 23003-060-US

Device Description : Tearaway introducer assembly (14 cm sheath)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030159 Catalog Number : 23004-US

Device Description : Pocket Tunneler

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030166 Catalog Number : 23005-US

Device Description : Torque Wrench

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030173 Catalog Number : 23006-US

Device Description : IPG Insertion Tool

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030180 Catalog Number : 23007-US

Device Description : Straw Tunneler

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030197 Catalog Number : 23012-030-US

Device Description : Stylet (straight, 30 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030203 Catalog Number : 23012-045-US

Device Description : Stylet (Straight, 45 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030210 Catalog Number : 23012-065-US

Device Description : Stylet (straight, 65 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030227 Catalog Number : 23013-050-US

Device Description : Lead Blank, 50 cm

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030258 Catalog Number : 34003-US

Device Description : EIC

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

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