Duns Number:026301221
Device Description: SHE TPY 15-20 TH OT Q NU 1 EN W/LACE TOP
Catalog Number
-
Brand Name
Activa Sheer Therapy
Version/Model Number
H20205
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
c909ce47-a607-4e32-8574-98b4cf5a508b
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
May 08, 2017
Package DI Number
04042809586367
Quantity per Package
36
Contains DI Package
00719869559191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3716 |