Catalog Number

-

Brand Name

IBC-Lite

Version/Model Number

0203010016

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142325

Product Code

KPT

Product Code Name

Calibrator, dose, radionuclide

Public Device Record Key

468e69da-7132-4e8c-baab-d9cfd59fac49

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-