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 carriersleeves 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 confirmedprostatic malignancy.
Catalog Number
F-01-01-0001
Brand Name
Sirius MRI Marker
Version/Model Number
F-01-01-0001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
e45b98bb-05d2-4353-ad95-95dc7da42655
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 21, 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 |