RICOH MEG

GUDID 04961311926266

RICOH COMPANY,LTD.

Magnetoencephalography system

• Primary Device ID: 04961311926266
• NIH Device Record Key: ddec91fd-98ab-489b-988b-0b354863ecfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RICOH MEG
• Version Model Number: RICOH160-1
• Company DUNS: 693055245
• Company Name: RICOH COMPANY,LTD.
• 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	04961311926266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040051

FDA Product Code

• OLX: Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-07