Nalu Medical, Inc. 71010-US

GUDID 00812537032924

Nalu Neurostimulation Kit (Integrated, Single 4, 40 cm, Tined)

NALU MEDICAL, INC.

Analgesic implantable peripheral nerve electrical stimulation system

Primary Device ID	00812537032924
NIH Device Record Key	69d2c69d-601f-4622-a8ec-e42f43a2c3e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nalu Medical, Inc.
Version Model Number	71010-US
Catalog Number	71010-US
Company DUNS	067140761
Company Name	NALU MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-618-3402
Email	info@nalumed.com

Device Dimensions

Length

40 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify

Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812537032924 [Primary]

FDA Product Code

GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-01-27
Device Publish Date	2020-01-17

On-Brand Devices [Nalu Medical, Inc.]

00812537032313	Lead Blank, 50 cm
00812537032672	Limb Cuff, Large (Black)
00812537032634	Limb Cuff (Black)
00812537032597	Relief Belt (Black)
00812537032535	Adhesive Test Patch Pack
00812537032511	Adhesive Clip Pack (H300)
00812537032498	Adhesive Clip Pack (H100)
00812537032474	Adhesive Clip Pack (H200)
00812537035574	Stylet (straight, 30 cm)
00812537032955	Lead Kit (4 contact, 40 cm, Tined)
00812537032924	Nalu Neurostimulation Kit (Integrated, Single 4, 40 cm, Tined)
00812537031057	Lead Kit (4 contact, 25 cm, Tined)
00812537031040	Lead Extension Kit (4)
00812537030999	Nalu Neurostimulation Kit (Ported, Single 4)
00812537030982	Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined)
00812537030944	Nalu Neurostimulation Kit (Integrated, Dual 8, 40 cm)
00812537031934	Trial Lead (8 contact, 60 cm)
00812537035680	Peripheral Nerve Stimulation Lead (8 contact, 60 cm)
00812537035666	Peripheral Nerve Stimulation Lead (8 contact, 40 cm)
00812537035642	Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
00812537035628	Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
00812537035604	Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
00812537033013	SCS Remote App (compatible with iOS)
00812537032863	Nalu Neurostimulation User's Kit
00812537032832	Nalu User's Trial Kit
00812537032566	Clinician Programmer
00812537032450	EIC Extension
00812537032436	EIC
00812537032290	Stylet (straight, 65 cm)
00812537032276	Stylet (Straight, 45 cm)
00812537032153	Straw Tunneler
00812537032139	IPG Insertion Tool
00812537032115	Torque Wrench
00812537032092	Pocket Tunneler
00812537032078	Tearaway introducer assembly (14 cm sheath)
00812537032054	Tearaway introducer assembly (10 cm sheath)
00812537032030	Stylet (Bent, 65 cm)
00812537032016	Stylet (Bent, 45 cm)
00812537031996	Spoonbill Needle (6"/15 cm)
00812537031972	Spoonbill Needle (4.5"/11 cm)
00812537031958	Anchor
00812537031859	Lead Extension (8 contact, 60 cm)
00812537031835	Lead (8 contact, 60 cm)
00812537031811	Lead (8 contact, 40 cm)
00812537031033	Lead Extension Kit (8)
00812537031026	Trial Lead Kit (8 contact, 60 cm)
00812537031019	Lead Kit (8 contact, 60 cm)
00812537031002	Lead Kit (8 contact, 40 cm)
00812537030975	Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm)
00812537030968	Nalu IPG Kit (Ported, Dual 8)