Duns Number:071018368
Device Description: The VasoStat Hemostasis Device is used to augment hemostasis through a ratcheting pressure The VasoStat Hemostasis Device is used to augment hemostasis through a ratcheting pressuremechanism.
Catalog Number
-
Brand Name
VasoStat Hemostasis Device
Version/Model Number
10348-325-04
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"
Yes
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
K153259,K153259
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
e1595749-a213-410c-871c-e7e31950527f
Public Version Date
June 04, 2021
Public Version Number
1
DI Record Publish Date
May 27, 2021
Package DI Number
10863879000208
Quantity per Package
10
Contains DI Package
00863879000201
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton