Duns Number:962520628
Device Description: ANGIO-SEAL STS Plus Vascular Closure Device
Catalog Number
610121
Brand Name
ANGIO-SEAL
Version/Model Number
610121
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
3d9db480-0535-4b35-a048-a4ef1366601f
Public Version Date
March 21, 2022
Public Version Number
7
DI Record Publish Date
April 20, 2017
Package DI Number
50389701011856
Quantity per Package
2
Contains DI Package
30389701011852
Package Discontinue Date
December 31, 2020
Package Status
Not 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 |