Catalog Number

3884

Brand Name

Proclaim™

Version/Model Number

3884

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

GZB

Product Code Name

STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Public Device Record Key

d95f0808-4ce1-41fa-b900-2797c845b399

Public Version Date

July 25, 2018

Public Version Number

3

DI Record Publish Date

March 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-