Duns Number:001188390
Device Description: Compu-cutter shielding bolck cutters cut foam block molds so that extremely precise alloy Compu-cutter shielding bolck cutters cut foam block molds so that extremely precise alloy blocks can be made to shield patients during radiation treatment.
Catalog Number
-
Brand Name
Compu-Cutter 111
Version/Model Number
CC3-1000
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
K940145
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
0c00eb91-ee3f-4c34-bcb6-17fe01646055
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 03, 2017
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |