FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
10812537030255
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
34003-US
Catalog number
34003-US
Device description
EIC
Published
2020-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
10812537030255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081253703025510812537030255

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic spinal cord electrical stimulation system pulse generator, externalAn electrically-powered, external component of a spinal cord electrical stimulation system intended to be used during a trial period (< 30 days) to noninvasively test operating parameters prior to implantation of the permanent system. It produces electrical signals intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneously implanted electrodes (not included) in the epidural space.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-20 Degrees Fahrenheit140 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0081253703743125cm Straight Stylet23012-0252026-02-26
0081253703744840cm Straight Stylet23012-0402026-02-26
00812537037462Extended Torque Wrench23005-0032026-02-26
00812537037691Lead Kit (4 Contact, 25cm, Tined)720062026-02-26
00812537037707Lead Kit (4-Contact, 40cm, Tined)720072026-02-26
00812537037141TD2 Limb Cuff340192026-02-25
00812537037158TD2 Thigh Wrap340182026-02-25
00812537037165TD2 Relief Belt, Large340162026-02-25
00812537037172TD2 Relief Belt, Small340172026-02-25
00812537037257Charger Kit74010-0012026-02-25
00812537037127TD2 Patient Kit740112026-02-20
00812537030234Therapy Disc34001-00134001-0012026-01-19
00812537032399Therapy Disc34001-00134001-0012026-01-19
00812537035802Therapy Disc, Reduced Warranty34001-00234001-0022026-01-19
00812537037134TD2 Therapy Disc34014-00134014-0012026-01-19
00812537037660Nalu Medical, Inc.72025720252025-12-08
00812537037189Nalu Medical, Inc.71005710052024-05-01
00812537037196Nalu Medical, Inc.71019710192024-05-01
00812537037202Nalu Medical, Inc.72001720012024-05-01
00812537037219Nalu Medical, Inc.72002720022024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00812537037332Nalu MedicalNALU MEDICAL, INC.GZF2024-05-01
00812537037349Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01