FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537034355
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
23006
Catalog number
23006
Device description
IPG Insertion Tool (15 cm)
Published
2022-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812537034355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537034355008125370343558125370343550812537034355

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
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
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
00812537037752Nalu™ User Trial KitNALU MEDICAL, INC.GZB2026-05-27
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030057Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030064Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030071Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030095Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030101Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030118Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030125Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030132Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030149Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030163Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030194Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
10812537030200Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
10812537030217Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21