Duns Number:185524860
Device Description: BrachySource® I125 SEEDS LOADED W SourceCaps™ IN MICK CRTDG, STERILE W PRELOADED NEEDLES
Catalog Number
1251CNF
Brand Name
Bard® BrachySource® I-125 Implant Seeds In Cartridges
Version/Model Number
1251CNF
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
K140856
Product Code
KXK
Product Code Name
Source, brachytherapy, radionuclide
Public Device Record Key
cd103e18-85e2-495d-860d-506ccbce0c9c
Public Version Date
October 31, 2022
Public Version Number
3
DI Record Publish Date
October 05, 2015
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |