Duns Number:135057938
Device Description: ULTRASCORE™ Focused Force PTA Balloon 4mm x 100mm, 130cm catheter
Catalog Number
US35130410
Brand Name
ULTRASCORE
Version/Model Number
US35130410
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
-
Product Code
PNO
Product Code Name
Catheter, percutaneous, cutting/scoring
Public Device Record Key
bdf30dba-b5dd-44ba-a4a2-ed76a85b7013
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
March 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |