4ch Flex SPEEDER

GUDID 04987670101342

4ch Flex SPEEDER

CANON MEDICAL SYSTEMS CORPORATION

MRI system coil, radio-frequency

• Primary Device ID: 04987670101342
• NIH Device Record Key: 71b63fff-49be-4433-b270-80bd5cd85dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4ch Flex SPEEDER
• Version Model Number: MJAJ-192A
• 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	04987670101342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112366

FDA Product Code

• MOS: Coil, magnetic resonance, specialty

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 [4ch Flex SPEEDER]

• 04987670101359: 4ch Flex SPEEDER
• 04987670101342: 4ch Flex SPEEDER