Duns Number:740449913
Device Description: Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous mang Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. To be used for re-verification of MRI scanner for the use of R2-MRI Analysis System (FerriScan)
Catalog Number
-
Brand Name
FerriScan Phantom Pack
Version/Model Number
15 vials (0 to 3.2 mM)
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
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
c9450f85-25e6-442e-94d4-77a98e802ace
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 10, 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. | 2 |