JOBST Relax - JOBST RELAX CCL2/THIGH HIGH/OPEN TOE/ROSE - BSN-Jobst GmbH

Duns Number:315917492

Device Description: JOBST RELAX CCL2/THIGH HIGH/OPEN TOE/ROSE

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More Product Details

Catalog Number

-

Brand Name

JOBST Relax

Version/Model Number

76098-00001-00

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)

-

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

MDR

Product Code Name

BINDER, MEDICAL, THERAPEUTIC

Device Record Status

Public Device Record Key

ae0502a6-a206-49cf-8355-8f04133badee

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

February 09, 2018

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