Catalog Number

TLEAD1058-50B

Brand Name

Senza

Version/Model Number

TLEAD1058-50B

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

10e95f1c-d0e1-43b0-b100-7054d42f4d07

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

April 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-