JOBST® Elvarex® - ELVAREX 4 SUPER/THIGH HIGH WITHOUT FOOT/KNEE - BSN-Jobst GmbH

Duns Number:315917492

Device Description: ELVAREX 4 SUPER/THIGH HIGH WITHOUT FOOT/KNEE FUNCTION/TOP COMFORT-WITHOUT VOLANT

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More Product Details

Catalog Number

-

Brand Name

JOBST® Elvarex®

Version/Model Number

79499-00073-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DWL

Product Code Name

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

Device Record Status

Public Device Record Key

9c8b9637-4a70-47d2-b943-ba61442ba002

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BSN-JOBST GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 13508