Duns Number:185524860
Device Description: Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, So Preloaded Needle Kits all consist of products (BrachySource® Iodine seeds, SourceLink™, SourceCaps™, Spacers) loaded into Brachytherapy needles
Catalog Number
1251PAF
Brand Name
Bard® BrachySource® I-125 Implant Seed Preloaded in Needles
Version/Model Number
1251PAF
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
b5d947b2-f5ed-4bae-8249-c654bd98ee80
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 |