Catalog Number

-

Brand Name

Trophon EPR

Version/Model Number

N00010-US-RFB

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

K103059,K103059

Product Code

OUJ

Product Code Name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers

Public Device Record Key

96ab12f0-86f4-4665-b211-dc9fb963204c

Public Version Date

March 19, 2021

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

09350855000139

Quantity per Package

1

Contains DI Package

09350855000122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-