MTS300 Cabinet, Steris, Standard - MTS 300 Sterilization Cabinet, Steris Standard - Stericube, LLC

Duns Number:079665067

Device Description: MTS 300 Sterilization Cabinet, Steris Standard

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More Product Details

Catalog Number

MTS300 Cabinet STR-0

Brand Name

MTS300 Cabinet, Steris, Standard

Version/Model Number

MTS300 Cabinet STR-0

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

K152014

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

cf7d2f06-d50e-42b4-9644-d17172dccc20

Public Version Date

October 19, 2022

Public Version Number

7

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERICUBE, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22