Duns Number:002751241
Device Description: Radioactive Seed Localization Needle with I-125 radioactive seed, 5 cm needle length.
Catalog Number
-
Brand Name
Advantage I-125®
Version/Model Number
RSLN-5
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
K141701
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
c599ab75-1c5a-4259-b01d-ea3f1edb59aa
Public Version Date
July 06, 2018
Public Version Number
3
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 |