Catalog Number

-

Brand Name

Rapicide Glutaraldehyde Indicator Test Strips

Version/Model Number

ML02-0120

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

K080750,K080750,K080750

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

a6c3e65e-f371-40b8-bce5-51564161aafa

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

March 07, 2018

Package DI Number

30677964063627

Quantity per Package

2

Contains DI Package

10677964063623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box