Duns Number:961027315
Device Description: 4305 WHITE TED T/L LARGE LONG
Catalog Number
4305-
Brand Name
T.E.D.
Version/Model Number
4305
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
-
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
d50c8b8b-84fa-4e8e-bdfc-08111ff019ea
Public Version Date
December 03, 2020
Public Version Number
1
DI Record Publish Date
November 25, 2020
Package DI Number
50192253015803
Quantity per Package
6
Contains DI Package
10192253015805
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |