FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537037196
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
71019
Catalog number
71019
Device description
Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812537037196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537037196008125370371968125370371960812537037196

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantableAn electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
067140761
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812537037752Nalu™ User Trial Kit740222026-05-27
10812537030125Nalu Medical, Inc.23002-065-US23002-065-US2020-04-21
10812537030194Nalu Medical, Inc.23012-030-US23012-030-US2020-04-21
10812537030200Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
10812537030217Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
00812537030203Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
00812537030210Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
00812537030227Nalu Medical, Inc.23013-050-US23013-050-US2020-04-21
00812537030487Nalu Medical, Inc.71001-US71001-US2020-04-21
00812537030494Nalu Medical, Inc.71002-US71002-US2020-04-21
00812537030791Nalu Medical, Inc.71006-US71006-US2020-04-21
00812537032252Nalu Medical, Inc.23012-030-US23012-030-US2020-04-21
00812537032894Nalu Medical, Inc.71010-US71010-US2020-04-21
00812537033471Nalu Medical, Inc.71001-US71001-US2020-04-21
00812537033488Nalu Medical, Inc.71002-US71002-US2020-04-21
00812537035260Nalu Medical, Inc.23002-045-US23002-045-US2020-04-21
00812537035345Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
00812537035352Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
00812537035505Nalu Medical, Inc.71006-US71006-US2020-04-21
00812537035529Nalu Medical, Inc.71010-US71010-US2020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537037752Nalu™ User Trial KitNALU MEDICAL, INC.GZF2026-05-27
0081253703743125cm Straight StyletNALU MEDICAL, INC.GZF2026-02-26
0081253703744840cm Straight StyletNALU MEDICAL, INC.GZF2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZF2026-02-26
00812537037691Lead Kit (4 Contact, 25cm, Tined)NALU MEDICAL, INC.GZF2026-02-26
00812537037707Lead Kit (4-Contact, 40cm, Tined)NALU MEDICAL, INC.GZF2026-02-26
00812537037141TD2 Limb CuffNALU MEDICAL, INC.GZF2026-02-25
00812537037158TD2 Thigh WrapNALU MEDICAL, INC.GZF2026-02-25
00812537037165TD2 Relief Belt, LargeNALU MEDICAL, INC.GZF2026-02-25
00812537037172TD2 Relief Belt, SmallNALU MEDICAL, INC.GZF2026-02-25
00812537037257Charger KitNALU MEDICAL, INC.GZF2026-02-25
00812537036984Base Station ChargerNALU MEDICAL, INC.GZF2026-02-24
00812537037127TD2 Patient KitNALU MEDICAL, INC.GZF2026-02-20
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZF2026-01-19
00812537037134TD2 Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537037660Nalu Medical, Inc.NALU MEDICAL, INC.GZF2025-12-08
00816986020549TalisMann Implant KitBIOVENTUS LLCGZF2025-09-01
00816986020556StimTrial Surgical KitBIOVENTUS LLCGZF2025-09-01
00816986020570StimTrial Patient KitBIOVENTUS LLCGZF2025-09-01
00816986020587StimTrial Stimulator KitBIOVENTUS LLCGZF2025-09-01
00816986020617Bioventus User KitBIOVENTUS LLCGZF2025-09-01
00816986020624Bioventus Clinician KitBIOVENTUS LLCGZF2025-09-01
00812537037189Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037202Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037219Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037226Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037233Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037332Nalu MedicalNALU MEDICAL, INC.GZF2024-05-01