Duns Number:332599307
Device Description: miniPhantom R used as Patient QA Phantom with MatriXX Resolution
Catalog Number
-
Brand Name
miniPhantom R
Version/Model Number
BS55000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
067881cb-7d79-4a94-8e43-a12a076c368f
Public Version Date
May 26, 2021
Public Version Number
1
DI Record Publish Date
May 18, 2021
Package DI Number
EIBABS550001
Quantity per Package
1
Contains DI Package
EIBABS550000
Package Discontinue Date
-
Package Status
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 |