FDA.reportPublic FDA data

Nalu Medical, Inc.

Primary DI
00812537034812
Brand
Nalu Medical, Inc.
Company
NALU MEDICAL, INC.
Model
23006
Catalog number
23006
Device description
IPG Insertion Tool
Published
2020-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00812537034812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537034812008125370348128125370348120812537034812

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA 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 and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

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
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
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.GZB2026-01-19
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032917Nalu 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
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030098Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030098Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030111Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030111Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030203Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21