CERAGEM Master V4

GUDID 08809494000075

CERAGEM Co., Ltd.

Large-area electric massager

• Primary Device ID: 08809494000075
• NIH Device Record Key: c21257f2-c917-431b-bc6a-23337da94f36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAGEM Master V4
• Version Model Number: CGM MB-1901
• Company DUNS: 688326136
• Company Name: CERAGEM Co., 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809494000075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202113

FDA Product Code

• JFB: Table, Physical Therapy, Multi Function

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

Devices Manufactured by CERAGEM Co., Ltd.

• 08809494000082 - CERAGEM Master V6: 2021-04-08
• 08809494000099 - CERAGEM Master V6: 2021-04-08
• 08809494000075 - CERAGEM Master V4: 2021-03-22
• 08809494000075 - CERAGEM Master V4: 2021-03-22
• 08809494000006 - CERAGEM Master V3: 2020-08-20