Duns Number:003065466
Device Description: The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjuncti The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
Catalog Number
F-01-01-0001
Brand Name
Sirius MRI Marker
Version/Model Number
C-01-99-0014
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2016
Issuing Agency
In GS1
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
K131689
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
3194bd8e-af20-4414-8ff2-5d9f40a72aed
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 19, 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. | 7 |