Duns Number:829616478
Device Description: MINERVA RF ControllerContents:(1) One MINERVA RF-Controller(1) One Footswitch(1) One Power MINERVA RF ControllerContents:(1) One MINERVA RF-Controller(1) One Footswitch(1) One Power Cord
Catalog Number
MIN180S
Brand Name
Minerva RF Controller
Version/Model Number
MIN180S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
P140013,P140013
Product Code
MNB
Product Code Name
Device, Thermal Ablation, Endometrial
Public Device Record Key
616980a4-1202-47ab-9316-570c5d70eae9
Public Version Date
January 21, 2022
Public Version Number
7
DI Record Publish Date
June 27, 2017
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 4 |