Duns Number:030650113
Device Description: PriZm Base System
Catalog Number
PRIZMSYS
Brand Name
PriZm
Version/Model Number
PRIZMSYS
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
FFX
Product Code Name
System, Gastrointestinal Motility (Electrical)
Public Device Record Key
dae380fd-49e2-4264-8ed0-80ddcd448c02
Public Version Date
October 26, 2020
Public Version Number
1
DI Record Publish Date
October 16, 2020
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 | 109 |
2 | A medical device with a moderate to high risk that requires special controls. | 207 |