Catalog Number

3716

Brand Name

Eon™

Version/Model Number

3716

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 17, 2018

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

79338e9b-951e-4d7b-a9f9-bc05a2af4238

Public Version Date

July 26, 2018

Public Version Number

3

DI Record Publish Date

October 23, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-