Duns Number:135057938
Device Description: CROSSER® CTO Recanalization Catheter 14S, Rapid Exchange, 106cm
Catalog Number
CRUS106
Brand Name
CROSSER®
Version/Model Number
CRUS106
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
PDU
Product Code Name
Catheter for crossing total occlusions
Public Device Record Key
a5e2f4d5-ff3a-4a31-a86e-00c202863a52
Public Version Date
April 17, 2018
Public Version Number
3
DI Record Publish Date
September 13, 2016
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 |