Catalog Number

-

Brand Name

n.a.

Version/Model Number

34-10-005

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"

Yes

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

IPW

Product Code Name

Orthosis, Sacroiliac, Soft

Public Device Record Key

a54abb6a-d564-4feb-9bbb-211772b80bb0

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

14250105612919

Quantity per Package

1

Contains DI Package

04250105612912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-