Duns Number:103665187
Device Description: The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coi The Promaxo Medium Receive Coil Model 6761-M is a 5-channel, receive-only phased array coil with external feedbox and fiducial coil to be used in conjunction with the Promaxo MRI System (PR071-001-M, PR071-001-R).
Catalog Number
6761-M
Brand Name
MRI Medium RX Coil (Receive Only)
Version/Model Number
6761-M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
9855129c-0d00-41ff-ba26-c8c98a73f22f
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
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. | 8 |