FusionMAX

Basic Information

• Brand Name: FusionMAX
• Primary DI: 00840343716707
• Version / Model: 33501-11-000
• Catalog Number: 33501-11-000
• Company Name: SURGIX MEDICAL LLC
• Labeler DUNS: 080402644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-07
• Public Version: 1
• Public Version Date: 2023-06-15
• Public Version Status: New
• Public Device Record Key: 031fdd58-668b-41e6-a0d5-250297fb769d

Device Description

Accessory Rail- moveable side rail for surgical table. Adjustable to full length of table by use of peg system. Designed for to support and secure surgical table attachments

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35954	Medical device service rail	A device designed to provide a secure, rapid, and safe method of mounting and organizing medical and non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in hospital wards, treatment rooms or an intensive care unit (ICU). It is usually fixed to a medical device service rail system, a medical device, or directly to a wall and in some cases it may be fixed to mobile devices. It will have a preformed cross-section incorporating a safety design compatible to the clamps expected to be mounted. It may be supplied in regular lengths which must be cut accordingly when fitted, or in prefabricated lengths.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840343716707	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]