Catalog Number

3346

Brand Name

NA

Version/Model Number

3346

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

K032751

Product Code

GZB

Product Code Name

STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Public Device Record Key

535bba9d-1c7f-495b-99ff-35e2116ee62d

Public Version Date

February 10, 2022

Public Version Number

5

DI Record Publish Date

April 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-