Catalog Number

1101

Brand Name

NA

Version/Model Number

1101

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LGW

Product Code Name

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Public Device Record Key

2f0d8e50-6e6d-4593-b591-cad5fd90da11

Public Version Date

January 20, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2014

Package DI Number

15414734400012

Quantity per Package

5

Contains DI Package

05414734400015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-