Duns Number:112719096
Device Description: The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 1H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
Catalog Number
-
Brand Name
32Ch Head Coil
Version/Model Number
MC 3003G-32R
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
4287da1d-1dc4-462c-9839-bd869ddd88f9
Public Version Date
August 30, 2021
Public Version Number
5
DI Record Publish Date
June 21, 2016
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. | 22 |