Duns Number:185524860
Device Description: BrachySource® I125 SEEDS AND SourceLinks™ IN THE ReadyLink™ CONFIG, STERILE
Catalog Number
STM1251RL
Brand Name
Bard® BrachySource® I-125 Implant Seeds In ReadyLink™
Version/Model Number
STM1251RL
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
K093663
Product Code
KXK
Product Code Name
Source, brachytherapy, radionuclide
Public Device Record Key
a4047bff-ba4c-43b3-8439-9cc754766976
Public Version Date
November 02, 2020
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 |