CERAGEM Master V3

Basic Information

• Brand Name: CERAGEM Master V3
• Primary DI: 08809494000006
• Version / Model: CGM MB-1101
• Company Name: CERAGEM Co., Ltd.
• Labeler DUNS: 688326136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 6
• Public Version Date: 2021-09-13
• Public Version Status: Update
• Public Device Record Key: 9cd89808-8d3c-47c2-a98e-b4fd261d0144

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JFB	Table, Physical Therapy, Multi Function	Physical Medicine	890.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32264	Massage table/couch, line-powered	A mains electricity (AC-powered) table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table is electrically adjusted. It may incorporate a face hole (the patient's face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809494000006	GS1

Premarket Submissions

Submission Number	Supplement Number
K140592	000