MULTI-PLANE TRANSESOPHAGEAL TRANSDUCER

GUDID 04987670004513

CANON MEDICAL SYSTEMS CORPORATION

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