Catalog Number

23012-025

Brand Name

Nalu Medical, Inc.

Version/Model Number

23012-025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GZB

Product Code Name

Stimulator, Spinal-Cord, Implanted (Pain Relief)

Public Device Record Key

5c4e6d3e-051a-4fcd-9497-3c9c21918900

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Package DI Number

10812537036653

Quantity per Package

5

Contains DI Package

00812537036656

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-