FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537032313
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
23013-050-US
Catalog number
23013-050-US
Device description
Lead Blank, 50 cm
Published
2019-09-23
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
00812537032313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537032313008125370323138125370323130812537032313

GMDN Terms#

Term, Definition table
TermDefinition
Implantable electrical stimulation system intraoperative test leadA flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Contacts#

Phone, Email table
PhoneEmail
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
00812537030272Nalu Medical, Inc.74007-00174007-0012026-08-07
00812537030296Nalu Medical, Inc.74007-00274007-0022026-08-07
00812537030883Nalu Medical, Inc.74007-00374007-0032026-08-07
00812537036953Nalu Medical, Inc.74017-00374017-0032026-08-07
00812537030104Nalu Medical, Inc.23001-060-US23001-0602020-04-21
00812537030227Nalu Medical, Inc.23013-050-US23013-0502020-04-21
00812537037462Extended Torque Wrench23005-00323005-0032026-02-26
00812537030159Nalu Medical, Inc.23004-US230042020-04-21
00812537030180Nalu Medical, Inc.23007-US230072020-04-21
00812537030333Nalu Medical, Inc.34007-US340072020-04-21
10812537030736Nalu Medical, Inc.34011-US340112020-04-21
10812537035588Nalu Medical, Inc.34009-US340092020-04-21
00812537030258Nalu Medical, Inc.34003-US340032020-04-21
00812537030265Nalu Medical, Inc.34004-US340042020-04-21
00812537030562Nalu Medical, Inc.72004-US720042020-04-21
00812537030081Nalu Medical, Inc.13001-US130012020-04-21
00812537037752Nalu™ User Trial Kit740222026-05-27
10812537030057Nalu Medical, Inc.12001-060-US12001-060-US2020-04-21
10812537030064Nalu Medical, Inc.12002-030-US12002-030-US2020-04-21
10812537030071Nalu Medical, Inc.12006-060-US12006-060-US2020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537030272Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537030296Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537030883Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537036953Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZF2026-02-26
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537034355Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537030630Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537031910Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537032986Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537035567Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537033822Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-10-12
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
00812537035734Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-06-24
00812537035741Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-06-24
00812537035758Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-06-24
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030098Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030111Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030203Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21