E3-10

GUDID 08800013513007

Alpinion Medical Systems 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

• Primary Device ID: 08800013513007
• NIH Device Record Key: a8902170-01ef-4b35-87fe-63ebc0f6d9c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E3-10
• Version Model Number: E3-10
• 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	08800013513007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132687

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: 2022-11-16
• Device Publish Date: 2016-09-23

Devices Manufactured by Alpinion Medical Systems Co., Ltd.

• 08800013510006 - L3-12: 2022-11-16
• 08800013510013 - L3-12H: 2022-11-16
• 08800013510020 - L3-8: 2022-11-16
• 08800013510044 - L3-12i: 2022-11-16
• 08800013510051 - L3-8i: 2022-11-16
• 08800013510068 - L8-17X: 2022-11-16
• 08800013510082 - L8-17i: 2022-11-16
• 08800013510099 - IO3-12: 2022-11-16