Catalog Number

NIPG1500

Brand Name

Senza®

Version/Model Number

NIPG1500

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)

-

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

cab471b0-af59-4957-8f6c-36c62219f5c0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-