SIUI - Digital Ultrasound Imaging System - Shantou Institute of Ultrasonic Instruments Co., Ltd.

Duns Number:654090299

Device Description: Digital Ultrasound Imaging System

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More Product Details

Catalog Number

-

Brand Name

SIUI

Version/Model Number

CTS-900

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081110

Product Code Details

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

054feb30-a910-4954-8cc7-3e8632cdf004

Public Version Date

December 21, 2018

Public Version Number

5

DI Record Publish Date

July 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 88