Catalog Number

-

Brand Name

Sonex-HL

Version/Model Number

N00037

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

Yes

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,K103059

Product Code

OUJ

Product Code Name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers

Public Device Record Key

990c6969-6ba0-4e5a-a4ce-37d53009f911

Public Version Date

March 19, 2021

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

09350855000078

Quantity per Package

2

Contains DI Package

09350855000061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer shipper