Catalog Number

-

Brand Name

trophon2

Version/Model Number

N05000-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K173865,K173865

Product Code

OUJ

Product Code Name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Public Device Record Key

4c659ccd-360d-4b2b-9393-c06aae45d593

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

June 15, 2018

Package DI Number

09350855000191

Quantity per Package

1

Contains DI Package

09350855000184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outershipper