Duns Number:617041967
Device Description: A custom manufactured solid Bolus Compensators for intensity modulation of external beam r A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy.
Catalog Number
-
Brand Name
.decimal Electron Bolus
Version/Model Number
1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091911
Product Code
IXI
Product Code Name
Block, Beam-Shaping, Radiation Therapy
Public Device Record Key
2b1d3ef1-9cbd-4de3-85cf-dfc98b080778
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |