Catalog Number

-

Brand Name

JOBST Elvarex

Version/Model Number

77429-01652-00

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

DWL

Product Code Name

Stocking, medical support (to prevent pooling of blood in legs)

Public Device Record Key

8e1bce3e-05e8-430f-b86c-f9ae570f16e7

Public Version Date

February 23, 2021

Public Version Number

1

DI Record Publish Date

February 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-