Catalog Number

GM11004700

Brand Name

Closed CT vaginal-cylinder, 23 mm diameter, with plastic clamping screw

Version/Model Number

GM11004700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K033371

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

db4bbf52-0cb0-4de9-99f6-7a01dedf9d31

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-