Catalog Number

TS200CS

Brand Name

Model 200 TheraSeed® Palladium-103 in Cartridges

Version/Model Number

TS200CS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Product Code

KXK

Product Code Name

Source, brachytherapy, radionuclide

Public Device Record Key

07388c24-23f3-427d-9107-6d606a1ad8b6

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

-