Catalog Number

12003-035-US

Brand Name

Nalu Medical, Inc.

Version/Model Number

12003-035-US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

GZF

Product Code Name

Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Public Device Record Key

9b9ba4da-5c32-4c16-91ac-ab3b3a691a88

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Package DI Number

10812537035748

Quantity per Package

5

Contains DI Package

00812537035741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-