Diagnostic Ultrasound System

GUDID 06970672750012

Guangzhou Sonostar Technologies Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06970672750012
• NIH Device Record Key: f9598fb4-51a7-4d28-997a-cb5d6451a3b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostic Ultrasound System
• Version Model Number: C5
• Company DUNS: 543263098
• Company Name: Guangzhou Sonostar Technologies Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970672750012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171926

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

[06970672750012]

Hydrogen Peroxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

Devices Manufactured by Guangzhou Sonostar Technologies Co., Ltd.

• 06970672750012 - Diagnostic Ultrasound System: 2019-04-09
• 06970672750012 - Diagnostic Ultrasound System: 2019-04-09
• 06970672750029 - Wireless Probe Type Ultrasound Scanner: 2019-04-09
• 06970672750043 - Wireless Probe Type Ultrasound Scanner: 2019-04-09