Catalog Number

S070023

Brand Name

NA

Version/Model Number

IsoCheck epid software

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

LHO

Product Code Name

Instrument, Quality-Assurance, Radiologic

Public Device Record Key

153e159e-e809-4bf1-9d42-2e08fa149022

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-