Pencil probe

GUDID 06945121410328

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06945121410328
• NIH Device Record Key: 59a3fb7b-b4ae-41fc-8fbf-e85a40785ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pencil probe
• Version Model Number: CW2-E
• 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	06945121410007 [Primary]
GS1	06945121410328 [Package]; Contains: 06945121410007; Package: [1 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Pencil probe]

• 06945121411592: CW2-V
• 06945121410328: CW2-E
• 06945121400275: D2D16L