FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537035741
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
12003-035-US
Catalog number
12003-035-US
Device description
Lead Extension (4 contact, 35 cm)
Published
2020-06-24
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
10812537035748PackageGS15In Commercial Distribution
00812537035741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081253703574810812537035748
00812537035741008125370357418125370357410812537035741

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extensionAn implantable device intended to extend the electrical connection between a spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator and a lead(s). It typically includes small connectors to enable attachment to the lead(s) and pulse generator, and a length of insulated wire; the lead(s) and pulse generator are not included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

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
true
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
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
10812537030095Nalu Medical, Inc.23001-045-US23001-045-US2020-04-21
10812537030101Nalu Medical, Inc.23001-060-US23001-060-US2020-04-21
10812537030118Nalu Medical, Inc.23002-045-US23002-045-US2020-04-21
10812537030125Nalu Medical, Inc.23002-065-US23002-065-US2020-04-21
10812537030132Nalu Medical, Inc.23003-045-US23003-045-US2020-04-21
10812537030149Nalu Medical, Inc.23003-060-US23003-060-US2020-04-21
10812537030163Nalu Medical, Inc.23005-US23005-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
10812537030224Nalu Medical, Inc.23013-050-US23013-050-US2020-04-21
00812537030050Nalu Medical, Inc.12001-060-US12001-060-US2020-04-21
00812537030067Nalu Medical, Inc.12002-030-US12002-030-US2020-04-21
00812537030074Nalu Medical, Inc.12006-060-US12006-060-US2020-04-21
00812537030098Nalu Medical, Inc.23001-045-US23001-045-US2020-04-21
00812537030104Nalu Medical, Inc.23001-060-US23001-060-US2020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZF2026-01-19
00812537035925Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-01-02
00812537036021Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-01-02
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
00812537036076Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537036083Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537036090Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537036106Nalu 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
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