HS70A

GUDID 08806167789008

SAMSUNG MEDISON CO., LTD.

General-purpose ultrasound imaging system

• Primary Device ID: 08806167789008
• NIH Device Record Key: 5fbbb4d9-fad9-40f8-a5a6-624f98841118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HS70A
• Version Model Number: USS-HS7AF3L/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	08806167789008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163691

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: 6
• Public Version Date: 2020-01-10
• Device Publish Date: 2017-11-17

On-Brand Devices [HS70A]

• 08806167789817: USS-HS7AF4L/US
• 08806167789176: USS-HS7AL4L/US
• 08806167789008: USS-HS7AF3L/US
• 08806167788834: USS-HS7AL3L/US
• 08806167764166: USS-HS7AF4K/US