Catalog Number

-

Brand Name

Kobold® Prostate HDR Stepper Template - 6 Fr

Version/Model Number

813-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

K170203

Product Code

JAQ

Product Code Name

System, Applicator, Radionuclide, Remote-Controlled

Public Device Record Key

3ce5d219-3984-48be-b9f7-e4bf9092e585

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-