JOBST Elvarex - ELVAREX FORTE 3/KNEE HIGH/SLANT-CLOSED - BSN-Jobst GmbH

Duns Number:315917492

Device Description: ELVAREX FORTE 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIASIS-VERSION/DOTTED 5 CM SILICONE BAND ELVAREX FORTE 3/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIASIS-VERSION/DOTTED 5 CM SILICONE BAND ON TOP/AUBERGINE

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More Product Details

Catalog Number

-

Brand Name

JOBST Elvarex

Version/Model Number

77425-01894-00

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

e9ce020c-38fa-4e81-bc4d-629f1f2150c1

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

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