FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537037233
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
72012
Catalog number
72012
Device description
Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00812537037233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537037233008125370372338125370372330812537037233

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connectionAn electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter

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
Lot or batch
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
00812537037196Nalu 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
00812537037332Nalu MedicalNALU MEDICAL, INC.GZF2024-05-01