Duns Number:964569052
Device Description: PROSTAR XL10F Percutaneous Vascular Surgical System
Catalog Number
12322-01
Brand Name
Prostar
Version/Model Number
12322-01
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"
-
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
f471e09b-c027-4b3a-b567-d87bed435ae5
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
November 21, 2014
Package DI Number
28717648000625
Quantity per Package
5
Contains DI Package
08717648000621
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |