C 1-8A

GUDID 08056304455765

ESAOTE SPA

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08056304455765
• NIH Device Record Key: 8ef8e245-2feb-4b3a-a22a-30f56b9a38e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C 1-8A
• Version Model Number: 120000146
• Company DUNS: 437384304
• Company Name: ESAOTE SPA
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056304455765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243253

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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by ESAOTE SPA

• 08056304455017 - MyLabA50: 2025-07-15
• 08056304455062 - 2CWL: 2025-07-15
• 08056304455079 - 5CWL: 2025-07-15
• 08056304455215 - MyLabE85: 2025-07-15
• 08056304455222 - P 1-5E: 2025-07-15
• 08056304455239 - C 1-8E: 2025-07-15
• 08056304455307 - MyLabA70: 2025-07-15
• 08056304455383 - L 3-15E: 2025-07-15