WS80A Diagnostic Ultrasound System

GUDID 08806167780081

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08806167780081
• NIH Device Record Key: 01ba3db6-7515-446c-a4fa-e92c2db3aa21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WS80A Diagnostic Ultrasound System
• Version Model Number: USS-WS8EF44/US
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	08806167780081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173513

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-10
• Device Publish Date: 2018-05-26

On-Brand Devices [WS80A Diagnostic Ultrasound System]

• 08806167780623: USS-WS8AL44/WW
• 08806167780081: USS-WS8EF44/US