Duns Number:008999906
Device Description: The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous an The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
Catalog Number
-
Brand Name
Vasc Band™ hemostat
Version/Model Number
3537
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
0553aaea-2223-4080-8e93-3dd9126e0088
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 2016
Package DI Number
M20635371
Quantity per Package
10
Contains DI Package
M20635370
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |