Catalog Number

LEAD3005-50B

Brand Name

Nevro®

Version/Model Number

LEAD3005-50B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2017

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)

-

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

f28cd1fb-45d9-4c2c-8775-751e3100e767

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

June 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-