Catalog Number

BI 108, BI 108/30

Brand Name

SteriTec Smart-Read Biological Test Pack with Instant Readout Integrator

Version/Model Number

BI 108

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

a4d6ee9c-c5bf-407b-b570-1fc40d796f80

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

20814434020053

Quantity per Package

30

Contains DI Package

00814434020059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case