AMSCO - AMSCO 1215 Cart and Utensil Washer/Disinfector, - Corporation Steris Canada

Duns Number:202659140

Device Description: AMSCO 1215 Cart and Utensil Washer/Disinfector, 380-400-415V, 50hz, Electric Heated has a AMSCO 1215 Cart and Utensil Washer/Disinfector, 380-400-415V, 50hz, Electric Heated has a small footprint that maximizes experiences by significantly reducing manual cleaning of case carts and containers.

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More Product Details

Catalog Number

FW12113

Brand Name

AMSCO

Version/Model Number

1215

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

3f20fee0-e667-4419-8611-f7ddfb003c06

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

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