FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537035505
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
71006-US
Catalog number
71006-US
Device description
Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined)
Published
2020-04-21
Public version status
Update
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
00812537035505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537035505008125370355058125370355050812537035505

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connectionAn implantable, 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), to transmit electrical impulses received transcutaneously from a skin surface electrode (not included) to the target nerves for the relief/treatment of acute and/or chronic intractable pain. It may include disposable devices associated with implantation and stabilization (e.g., introducer, stylet, adhesive pad).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Centimeter

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

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
00812537035529Nalu Medical, Inc.71010-US71010-US2020-04-21
00812537037141TD2 Limb Cuff340192026-02-25

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
00812537037233Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01