Duns Number:305116642
Device Description: Gamma Camera System
Catalog Number
9PMS3060
Brand Name
CardioMD
Version/Model Number
CorCam Gamma Camera System
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011611
Product Code
KPS
Product Code Name
System, Tomography, Computed, Emission
Public Device Record Key
4b283b3a-ca80-481f-8fe8-11c043f0fd04
Public Version Date
August 06, 2018
Public Version Number
1
DI Record Publish Date
July 04, 2018
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 8 |