Duns Number:312844095
Device Description: The intended use of MR-BI320-PA 1.5T/3T is, in conjunction with a Magnetic Resonance Scann The intended use of MR-BI320-PA 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast.
Catalog Number
MR10062-MHA
Brand Name
Vacuum gun-adapter for PP system for Invivo Multi Hub Assembly
Version/Model Number
01
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
K081118,K082373
Product Code
MOS
Product Code Name
Coil, Magnetic Resonance, Specialty
Public Device Record Key
137285bc-e938-4ea1-b8d8-81ec47e6e183
Public Version Date
July 14, 2022
Public Version Number
1
DI Record Publish Date
July 06, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |