Catalog Number

-

Brand Name

Vaginal CT/MR Multi Channel Applicator

Version/Model Number

110750-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111973,K111973

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

9202589d-8b5b-4cde-85b1-9fe0d044cfa8

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-