Duns Number:002751241
Device Description: Radioactive Seed Localization with I-125 seed, spacer, strand. 20 cm Needle
Catalog Number
-
Brand Name
Advantage I-125®
Version/Model Number
RSLN-20
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,K141701
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
ef995e5d-08a1-41df-9dc4-0aaa75e83f53
Public Version Date
February 15, 2022
Public Version Number
1
DI Record Publish Date
February 07, 2022
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 |