ULTRASOUND WORKSTATION PACKAGE

GUDID 04987670100796

ULTRASOUND WORKSTATION PACKAGE

CANON MEDICAL SYSTEMS CORPORATION

Ultrasound imaging system workstation

• Primary Device ID: 04987670100796
• NIH Device Record Key: ba61f126-a834-4d20-8580-15a717e211d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRASOUND WORKSTATION PACKAGE
• Version Model Number: TUW-U001S
• 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	04987670100796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121076

FDA Product Code

• IYL: Collimator, dermatological, therapeutic x-ray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [ULTRASOUND WORKSTATION PACKAGE]

• 04987670101014: ULTRASOUND WORKSTATION PACKAGE
• 04987670100796: ULTRASOUND WORKSTATION PACKAGE