SC2-11H

GUDID 08800013511157

ALPINION MEDICAL SYSTEMS CO.,LTD

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08800013511157
• NIH Device Record Key: ae6c6205-239f-4f85-a0dc-ca922d05db80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SC2-11H
• Version Model Number: SC2-11H
• Company DUNS: 557800655
• Company Name: ALPINION MEDICAL SYSTEMS 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800013511157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211299

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2021-08-20
• Device Publish Date: 2021-08-12

Devices Manufactured by ALPINION MEDICAL SYSTEMS CO.,LTD

• 08800013510037 - L3-12HWD: 2022-11-02
• 08800013510075 - L3-12X: 2022-11-02
• 08800013510150 - L3-8H: 2022-11-02
• 08800013512093 - P1-5CT: 2022-11-02
• 08800013513076 - EC3-10T: 2022-11-02
• 08800013513083 - EV3-10T: 2022-11-02
• 08800013515001 - VE3-10H: 2022-11-02
• 08800013519016 - CW5.0: 2022-11-02