Catalog Number

-

Brand Name

DC-80 PRO

Version/Model Number

DC-80 PRO

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173471

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

9ed8ca44-9a8b-4e49-b104-c30f6837e3d8

Public Version Date

August 27, 2018

Public Version Number

1

DI Record Publish Date

July 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-