Duns Number:781746586
Catalog Number
160-00050
Brand Name
CorPath 200 Robotic Drive
Version/Model Number
160-00050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 06, 2019
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
-
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
DXX
Product Code Name
System, Catheter Control, Steerable
Public Device Record Key
506b28de-5622-4f11-9266-5e22714f4152
Public Version Date
October 19, 2022
Public Version Number
4
DI Record Publish Date
September 24, 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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |