EBit Trolly

GUDID 06945121410854

CHISON Medical Technologies Co., Ltd.

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• Primary Device ID: 06945121410854
• NIH Device Record Key: fd61887c-bfc6-45f3-959d-fb09c8cd5b62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBit Trolly
• Version Model Number: TR-10
• Company DUNS: 544914187
• Company Name: CHISON Medical Technologies 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	06945121410854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162172

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-06

On-Brand Devices [EBit Trolly]

• 06945121410854: TR-10
• 06945121410670: ETR