Duns Number:024942265
Device Description: The Odyssey Workstation is an optional display and user interface package designed to cons The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Catalog Number
001-007010-2
Brand Name
Odyssey
Version/Model Number
Quad HD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K072371
Product Code
DXX
Product Code Name
System, Catheter Control, Steerable
Public Device Record Key
8e9177c2-9a61-483f-8b70-9ca6b3814a5b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |