Catalog Number

-

Brand Name

NA

Version/Model Number

101160-03

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 08, 2018

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080934,K091154,K132889,K983341

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

7090c387-f54f-47fe-9921-433820c92c72

Public Version Date

September 10, 2018

Public Version Number

2

DI Record Publish Date

June 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-