Duns Number:157308230
Catalog Number
-
Brand Name
Sun Nuclear CT Electron Density Phantom
Version/Model Number
467
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
LHO
Product Code Name
Instrument, Quality-Assurance, Radiologic
Public Device Record Key
b81c0b20-eb68-4f30-b15b-f95b79f6cb93
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 13, 2021
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 | 72 |