SP3-8

GUDID 08806167798048

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08806167798048
• NIH Device Record Key: c499e785-4a2e-40e4-bb5e-ede8fa9ab6bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SP3-8
• Version Model Number: USP-P038NSA/WR
• 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	08806167798048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143264

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-28

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

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• 08800290027334 - LA2-9Sn: 2026-01-28
• 08800290027365 - CA3-10An: 2026-01-28
• 08800290031522 - HERA Z20e Diagnostic Ultrasound System: 2026-01-28