Duns Number:185524860
Device Description: Model 200 TheraSeed® Palladium-103 Seeds IN ISOSLEEVE, STRL
Catalog Number
IS200
Brand Name
Model 200 TheraSeed® Palladium-103 Device in Isosleeve™ Delivery System
Version/Model Number
IS200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 15, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K060636,K060636
Product Code
KXK
Product Code Name
Source, brachytherapy, radionuclide
Public Device Record Key
2976e508-c14b-470c-a1b8-134899913913
Public Version Date
October 31, 2022
Public Version Number
4
DI Record Publish Date
October 05, 2015
Package DI Number
10801741078511
Quantity per Package
1
Contains DI Package
00801741078514
Package Discontinue Date
June 15, 2021
Package Status
Not in Commercial Distribution
Package Type
Other
| 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 |