Catalog Number

-

Brand Name

Transonic

Version/Model Number

HCS3012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2021

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080116

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Public Device Record Key

197039e8-0365-4102-a854-a7565dd2eb5f

Public Version Date

January 25, 2021

Public Version Number

4

DI Record Publish Date

April 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-