Duns Number:006133784
Device Description: Footswitch ASU2/ASU3
Catalog Number
A000049
Brand Name
Synergy™ Ablation System
Version/Model Number
ASU
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
-
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
OCM
Product Code Name
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Public Device Record Key
0e8bae34-d514-4256-b190-aa21a70dc7b4
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
December 31, 2019
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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |