Catalog Number

7140

Brand Name

Pro Comfort Universal Lumbar Support Back Brace

Version/Model Number

62350

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MRI

Product Code Name

Orthosis, Truncal/Orthosis, Limb

Public Device Record Key

4086c9ff-8e83-4000-8546-eb47b903cb0e

Public Version Date

September 07, 2018

Public Version Number

1

DI Record Publish Date

August 07, 2018

Package DI Number

10850632007147

Quantity per Package

20

Contains DI Package

00850632007140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case