Duns Number:961027315
Device Description: 3416 LF TED STKG NYL T/L MR
Catalog Number
3416LF-
Brand Name
T.E.D.
Version/Model Number
3416LF
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)
Yes
Over the Counter (OTC)
-
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
ab4f2d03-8d19-4035-adee-951a3b569983
Public Version Date
August 18, 2021
Public Version Number
1
DI Record Publish Date
August 10, 2021
Package DI Number
20192253015475
Quantity per Package
6
Contains DI Package
10192253015478
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |