Duns Number:002751241
Device Description: Advantage I-125® radioactive seeds with a molded form that is shielded on one side and con Advantage I-125® radioactive seeds with a molded form that is shielded on one side and contains grooved positions for manual brachytherapy sources on the other side and is used for the temporary topical application of brachytherapy sources to the surface of the eye.
Catalog Number
-
Brand Name
Advantage I-125®
Version/Model Number
IEPS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
e2217c2c-8d14-4c29-a8fc-f96954727b57
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 04, 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 |
|---|---|---|
| 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. | 19 |