Catalog Number

N00099

Brand Name

trophon Curved Probe Positioner

Version/Model Number

N00099

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, Mist

Public Device Record Key

dc7eaa24-60a0-47a7-b82c-2a3b1c025d43

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-