EV2-12

GUDID 08800290042542

SAMSUNG MEDISON CO., LTD.

Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 08800290042542
• NIH Device Record Key: fedefc4c-981f-4190-9cf7-87a9013864dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EV2-12
• Version Model Number: USP-VN2CFFA/WR
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	08800290042542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241971

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: 2025-12-15
• Device Publish Date: 2025-12-05

On-Brand Devices [EV2-12]

• 08809880020021: USP-VF2CF1A/WR
• 08800290042542: USP-VN2CFFA/WR