Crosszyme Concentrated Ultrasonic Cleaner - Ultrasonic Cleaner, Enzymatic Formula with Rust - CROSSTEX INTERNATIONAL, INC.

Duns Number:057728685

Device Description: Ultrasonic Cleaner, Enzymatic Formula with Rust Inhibitor

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More Product Details

Catalog Number

-

Brand Name

Crosszyme Concentrated Ultrasonic Cleaner

Version/Model Number

JEZ

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

7c5c3ea2-4553-487b-a0b2-6e9393cd123c

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Additional Identifiers

Package DI Number

50732224016462

Quantity per Package

4

Contains DI Package

10732224016464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CROSSTEX INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 25