Duns Number:809529469
Device Description: Microwave Ablation System Accessory
Catalog Number
FPRCH9010
Brand Name
HEATfx Cart
Version/Model Number
FPRCH9010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 14, 2020
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
ff807781-732f-47f0-ba97-d457ed92fe88
Public Version Date
September 03, 2021
Public Version Number
3
DI Record Publish Date
August 14, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 43 |