Duns Number:415269930
Device Description: Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quan Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quantity in package is customer order specific in range 10 – 100 seeds.
Catalog Number
130002
Brand Name
selectSeed™ I-125
Version/Model Number
130002-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K002429,K002429
Product Code
KXK
Product Code Name
Source, Brachytherapy, Radionuclide
Public Device Record Key
fa0885c5-5aaa-4fe3-bf22-fc109bddc59e
Public Version Date
July 17, 2019
Public Version Number
5
DI Record Publish Date
October 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1904 |