Duns Number:609397224
Device Description: The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
Catalog Number
TWSR
Brand Name
AeroWrap Thigh Small Right
Version/Model Number
TW6150-03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 22, 2030
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
76862d72-2a90-44d4-8bd2-acb567417c75
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 13, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |