Duns Number:080935429
Device Description: Anti-Embolism Stockings for Continuing Care,Thigh Length,White,Medium,Regular
Catalog Number
4301
Brand Name
T.E.D.
Version/Model Number
4301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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
-
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
18eae45b-fed6-4c31-8495-e3d994a7eef4
Public Version Date
January 06, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
30884521024612
Quantity per Package
6
Contains DI Package
20884521024615
Package Discontinue Date
July 01, 2023
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 |