Micro-Scientific Opti-Cide3 - Disinfectant solution - MICRO-SCIENTIFIC, LLC

Duns Number:080214481

Device Description: Disinfectant solution

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More Product Details

Catalog Number

-

Brand Name

Micro-Scientific Opti-Cide3

Version/Model Number

NE20GC

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

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 Details

Product Code

LRJ

Product Code Name

Disinfectant, Medical Devices

Device Record Status

Public Device Record Key

8de2191b-40da-4605-a488-ca70f3c7a181

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Additional Identifiers

Package DI Number

10739470100046

Quantity per Package

2

Contains DI Package

00739470100049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MICRO-SCIENTIFIC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 1