CA1-7A

GUDID 08809702985484

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08809702985484
• NIH Device Record Key: 9c5370c9-ccd7-4a6e-8b75-5fe73f930c84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CA1-7A
• Version Model Number: USP-C017FSE/WR
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809702985484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152962

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: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [CA1-7A]

• 08809521023626: USP-C017FSD/WR
• 08809702985484: USP-C017FSE/WR
• 08806167765743: USP-RC017FSBWR