MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER

GUDID 04987670004513

CANON MEDICAL SYSTEMS CORPORATION

Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable Oesophageal ultrasound imaging transducer, reusable

• Primary Device ID: 04987670004513
• NIH Device Record Key: dce660a1-a927-45f7-a18c-d67c98194941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
• Version Model Number: PEI-512VX
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• 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	04987670004513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151451

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: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER]

• 04987670004520: MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
• 04987670003103: MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
• 04987670000607: MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
• 04987670000584: MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER
• 04987670004513: PEI-512VX