Prolystica - Prolystica 2X Concentrate Alkaline 15-Gallon is - STERIS CORPORATION

Duns Number:139424188

Device Description: Prolystica 2X Concentrate Alkaline 15-Gallon is an alkaline pH liquid detergent used in th Prolystica 2X Concentrate Alkaline 15-Gallon is an alkaline pH liquid detergent used in the removal of a broad range of soils from surgical instruments and medical devices in the manual and automated cleaning process.

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More Product Details

Catalog Number

1C34P3

Brand Name

Prolystica

Version/Model Number

1C34P3

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

FLG

Product Code Name

Cleaner, ultrasonic, medical instrument

Device Record Status

Public Device Record Key

a0f888d5-f8c5-483d-a426-a49bc50a32f9

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

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