ENDOVAGINAL TRANSDUCER

GUDID 04987670001642

ENDOVAGINAL TRANSDUCER

CANON MEDICAL SYSTEMS CORPORATION

Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 04987670001642
• NIH Device Record Key: 73194827-adb5-4779-bd69-5e52962e7742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOVAGINAL TRANSDUCER
• Version Model Number: PVM-651VT
• 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

Customer Support Contacts

• Phone: +1-8004211968
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670001642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061605

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04987670001642]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [ENDOVAGINAL TRANSDUCER]

• 04987670001642: ENDOVAGINAL TRANSDUCER
• 04987670001635: ENDOVAGINAL TRANSDUCER