Catalog Number

S8T-1A US

Brand Name

Freedom Spinal Cord Stimulator System

Version/Model Number

FR8A-TRL-A0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

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

K150517

Product Code

GZB

Product Code Name

Stimulator, Spinal-Cord, Implanted (Pain Relief)

Public Device Record Key

d7086e1b-847c-480d-a61d-db3e5098cc0c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-