AMSCO - The AMSCO 7053L Single-Chamber - Corporation Steris Canada

Duns Number:202659140

Device Description: The AMSCO 7053L Single-Chamber Washer-Disinfector, Steam Unit is designed for cleaning and The AMSCO 7053L Single-Chamber Washer-Disinfector, Steam Unit is designed for cleaning and intermediate-level disinfection of soiled reusable utensils, trays, bedpans and urinals. It can also be used for rubber and plastic goods, simple hard-surfaced rigid surgical instruments (such as forceps and clamps) and other similar and related articles found in healthcare facilities.

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More Product Details

Catalog Number

FH96062

Brand Name

AMSCO

Version/Model Number

7053L

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

MEC

Product Code Name

Disinfector, medical devices

Device Record Status

Public Device Record Key

236a4f10-9256-4df2-9ef9-c196d4d2e2c0

Public Version Date

January 28, 2021

Public Version Number

2

DI Record Publish Date

September 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORPORATION STERIS CANADA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 262