Catalog Number

-

Brand Name

Advantage I-125®

Version/Model Number

RSLN-12

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)

Yes

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

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

13a09b3a-9f6d-49c2-8fc9-91178bb77e15

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-