Duns Number:809758878
Device Description: Upgrade to Certus 140-2.45GHz Ablation Confirmation
Catalog Number
AC-UPGRADE
Brand Name
NEUWAVE
Version/Model Number
AC-UPGRADE
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
K192427
Product Code
JAK
Product Code Name
System, x-ray, tomography, computed
Public Device Record Key
d1df0ac5-0f7e-4eee-b740-841568ab55ee
Public Version Date
May 18, 2021
Public Version Number
2
DI Record Publish Date
May 06, 2021
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 |