Duns Number:332599307
Device Description: miniPhantom R used as Patient QA Phantom with MatriXX Resolution
Catalog Number
-
Brand Name
miniPhantom R
Version/Model Number
M1090000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2021
Issuing Agency
In HIBCC
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
IXG
Product Code Name
Phantom, Anthropomorphic, Radiographic
Public Device Record Key
e34667a6-8b17-4bb7-a8f9-7f28422c434a
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
April 07, 2021
Package DI Number
EIBAM10900001
Quantity per Package
1
Contains DI Package
EIBAM10900000
Package Discontinue Date
April 21, 2021
Package Status
Not in Commercial Distribution
Package Type
Carry Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |