Catalog Number

-

Brand Name

Theragenics

Version/Model Number

0811-53

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K071550

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

3270b5e3-45ff-4f97-8086-d2be57bcb064

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

July 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-