Catalog Number

71007-US

Brand Name

Nalu Medical, Inc.

Version/Model Number

71007-US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

a6698b86-9053-4cd7-9b1e-292f76390073

Public Version Date

April 29, 2020

Public Version Number

1

DI Record Publish Date

April 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-