Duns Number:080935429
Device Description: Anti-Embolism Stockings,Knee Length, Large, Long, White
Catalog Number
MKN34920
Brand Name
T.E.D.
Version/Model Number
MKN34920
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
DWL
Product Code Name
Stocking, medical support (to prevent pooling of blood in legs)
Public Device Record Key
b111ef9f-c59a-448d-9e68-8c977c244346
Public Version Date
July 07, 2020
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521167039
Quantity per Package
12
Contains DI Package
00884521167035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |