Duns Number:566622973
Device Description: Magnetic coil for he Axilum Robotics’ TMS-Cobot TS MV solution (K182768) which is an acces Magnetic coil for he Axilum Robotics’ TMS-Cobot TS MV solution (K182768) which is an accessory to the predicate MagVenture TMS Therapy System (K150641, K171481 and K171967).
Catalog Number
9016E0151
Brand Name
MagPro
Version/Model Number
Cool-B65 CO
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
-
Product Code
GWF
Product Code Name
Stimulator, Electrical, Evoked Response
Public Device Record Key
efaf7985-1e0b-4032-9135-607b8a345845
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
April 29, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |