Duns Number:962520628
Device Description: ANGIO-SEAL VIP Vascular Closure Device
Catalog Number
610131
Brand Name
ANGIO-SEAL
Version/Model Number
610131
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
MGB
Product Code Name
Device, hemostasis, vascular
Public Device Record Key
602b01a8-8b01-4a11-af10-fdc5b2080d50
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
April 20, 2017
Package DI Number
50389701011818
Quantity per Package
2
Contains DI Package
30389701011814
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| 3 | A medical device with high risk that requires premarket approval | 4 |