Catalog Number

-

Brand Name

NA

Version/Model Number

083926P02-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2017

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

-

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

368a33d8-882c-4083-b2fc-e0c75ed9cd8b

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

December 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-