MetriCide OPA Plus - orthoPhthalaldehyde Solution high level - METREX RESEARCH, LLC

Duns Number:145963778

Device Description: orthoPhthalaldehyde Solution high level disinfectant for semicritical medical devices

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More Product Details

Catalog Number

-

Brand Name

MetriCide OPA Plus

Version/Model Number

10-6000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MED

Product Code Name

Sterilant, medical devices

Device Record Status

Public Device Record Key

87067a07-9795-4fcc-9549-76a6b1832af9

Public Version Date

November 11, 2021

Public Version Number

6

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

10615375006433

Quantity per Package

4

Contains DI Package

00615375006436

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"METREX RESEARCH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 6