line array probe

GUDID 06945121414265

CHISON Medical Technologies 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: 06945121414265
• NIH Device Record Key: 26d20283-90da-4836-baec-30da4658bc5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: line array probe
• Version Model Number: L7R-T
• 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: true
• 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	06945121414265 [Primary]
GS1	06945121414432 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200780

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: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [line array probe]

• 06945121413527: L12M-T
• 06945121414135: L18-T
• 06945121414272: L10i-T
• 06945121414265: L7R-T