Catalog Number

-

Brand Name

JOBST Elvarex

Version/Model Number

79586-00038-00

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

ef051509-3a37-492e-ad2a-78344c70fd98

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-