MTS300 Transfer Cart, FL, Universal - MTS300 Transfer Cart, Floor Loader, Universal - Stericube, LLC

Duns Number:079665067

Device Description: MTS300 Transfer Cart, Floor Loader, Universal

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More Product Details

Catalog Number

MTS300 Transfer Cart MTS-TC-FL

Brand Name

MTS300 Transfer Cart, FL, Universal

Version/Model Number

MTS300 Transfer Cart MTS-TC-FL

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

2457e5f5-f963-4173-8741-8ea8966db165

Public Version Date

October 19, 2022

Public Version Number

7

DI Record Publish Date

January 24, 2017

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