Catalog Number

-

Brand Name

JOBST Elvarex

Version/Model Number

77422-00063-00

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

2f714e15-c395-4f5a-a015-13855fccb16b

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-