Envirocide - Surface Disinfectant Decontaminant Cleaner - METREX RESEARCH, LLC

Duns Number:145963778

Device Description: Surface Disinfectant Decontaminant Cleaner

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More Product Details

Catalog Number

-

Brand Name

Envirocide

Version/Model Number

13-3324

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

LRJ

Product Code Name

Disinfectant, medical devices

Device Record Status

Public Device Record Key

fe5e1ab9-46ab-4e0e-bda0-bef46a683a2f

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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