Catalog Number

BD 116

Brand Name

SteriTec Green Card Bowie-Dick Test Starter Kit

Version/Model Number

BD 116

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

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

9c922074-0781-43e3-9216-7374852ea269

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

30814434020715

Quantity per Package

8

Contains DI Package

20814434020718

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case