VERIFY - The VERIFY Incubator is for exclusive use with - STERIS CORPORATION

Duns Number:868205779

Device Description: The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Ind The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicators and VERIFY Process Challenge Devices.

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More Product Details

Catalog Number

LCB030

Brand Name

VERIFY

Version/Model Number

LCB030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2022

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

OWP

Product Code Name

Biological sterilization process indicator with recombinant-dna plasmid

Device Record Status

Public Device Record Key

4e01c04d-bee9-4370-87ab-4caabd335f34

Public Version Date

April 25, 2022

Public Version Number

5

DI Record Publish Date

April 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557