EV2-10A

GUDID 08806167799304

SAMSUNG MEDISON CO., LTD.

Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 08806167799304
• NIH Device Record Key: 35d34f75-4f23-4abc-93f9-8b8e3cd67c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EV2-10A
• Version Model Number: USP-V02AN1A/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	08806167799304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200339

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [EV2-10A]

• 08809702986542: USP-V02AN1B/WR
• 08809702986481: USP-V02AF1B/WR
• 08806167799304: USP-V02AN1A/WR
• 08806167799014: USP-V02AF1A/WR