Catalog Number

-

Brand Name

Advantage Pd-103®

Version/Model Number

PLVN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K033770,K033770

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

7bcc38d6-b321-4e0f-82e9-f8d5f7e7cd5e

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

-