Catalog Number

3161

Brand Name

Quattrode®

Version/Model Number

3161

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 28, 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

K072462

Product Code

GZB

Product Code Name

STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Public Device Record Key

3ea88727-893d-4847-aa2e-7686ea9de4ba

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

November 13, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-