Catalog Number

11620003Z

Brand Name

1-4 MV ISORAD Detector (3m Cable)

Version/Model Number

11620003Z

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 2019

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

K912250

Product Code

IWB

Product Code Name

System, Radiation Therapy, Radionuclide

Public Device Record Key

8a5eb46c-e6e8-419c-a568-8275a6f860f8

Public Version Date

June 18, 2019

Public Version Number

5

DI Record Publish Date

January 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-