Catalog Number

1204-02-EZ-1.65

Brand Name

CT/MR Contour Prostate Template, Small Matrix B&K 1.65mm - EZ BEBIG

Version/Model Number

1204-02-EZ-1.65

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

K993400

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Public Device Record Key

087edd63-061b-4ff8-bb50-1065964e0677

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-