DR COMFORT - SS KneeHs W 30-40 Nude MD - DJO, LLC

Duns Number:081840873

Device Description: SS KneeHs W 30-40 Nude MD

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More Product Details

Catalog Number

-

Brand Name

DR COMFORT

Version/Model Number

701433

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

92227ba8-9555-4a8e-abbf-8917d519c187

Public Version Date

July 28, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DJO, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 784
2 A medical device with a moderate to high risk that requires special controls. 1030
3 A medical device with high risk that requires premarket approval 8