Duns Number:332599307
Device Description: PPC05 Parallel plate chamber for electron beams, 0.05 ccm, BNC triax - suitable for all PPC05 Parallel plate chamber for electron beams, 0.05 ccm, BNC triax - suitable for all phantom cut-outs and holders originally designed for the "Markus" chamber
Catalog Number
-
Brand Name
PPC05 Parallel plate chamber for electron beams
Version/Model Number
DS30-100
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
7627a9b1-290d-487e-9067-b8524dc7a8b4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
EIBADS301001
Quantity per Package
1
Contains DI Package
EIBADS301000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Chamber 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 |