Catalog Number

ACCK8012-70

Brand Name

Nevro®

Version/Model Number

ACCK8012-70

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P130022

Product Code

LGW

Product Code Name

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Public Device Record Key

9449c2d3-9759-470b-8cff-3d9e5318f3dd

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

May 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-