Phi 100 Flex coil

GUDID 04987670101519

Phi 100 Flex coil

CANON MEDICAL SYSTEMS CORPORATION

MRI system coil, radio-frequency

• Primary Device ID: 04987670101519
• NIH Device Record Key: bfe2b9c9-05a1-46db-8e11-591c68e30d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phi 100 Flex coil
• Version Model Number: MJLC-107H
• 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	04987670101519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141472

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-01

On-Brand Devices [Phi 100 Flex coil]

• 04987670101519: Phi 100 Flex coil
• 04987670101496: Phi 100 Flex coil