Duns Number:809758878
Device Description: Certus 140 2.45GHz Ablation System, 120 VAC
Catalog Number
DR-000551
Brand Name
Certus® 140
Version/Model Number
2.45 GHz Ablation System
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
NEY
Product Code Name
SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
Public Device Record Key
1021043b-1ba5-4707-ab29-d7bc23310ba2
Public Version Date
May 18, 2021
Public Version Number
3
DI Record Publish Date
September 18, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |