FusionMAX 33501-18-000

GUDID 00840343716639

Chest Support Plate: removable carbon fiber plate with locking mechanism. Used in conjunction with cushion to provide comfort and protection to patient in prone position.

SURGIX MEDICAL LLC

Operating table patient positioning set, reusable

• Primary Device ID: 00840343716639
• NIH Device Record Key: bd075a5a-3be4-4da7-9697-8e5e059a3b12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FusionMAX
• Version Model Number: 33501-18-000
• Catalog Number: 33501-18-000
• Company DUNS: 080402644
• Company Name: SURGIX MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com
• Phone: 888-247-0477
• Email: customerservice@surgixmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840343716639 [Primary]

FDA Product Code

• JEA: Table, Surgical With Orthopedic Accessories, Ac-Powered

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: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [FusionMAX]

• 00840343716745: Lower Body Support Plate: removable carbon fiber plate with locking mechanisms. Used in conjunct
• 00840343716684: Foot Pillow: memory foam cushion used in conjunction with patient positioner in prone position,
• 00840343716677: Angled Pelvic Support Pad: memory foam cushion used to provide comfort and protect patient in pr
• 00840343716646: Supine Table Pad: memory foam cushion designed to be use in conjunction with the Supine Platform
• 00840343716639: Chest Support Plate: removable carbon fiber plate with locking mechanism. Used in conjunction wi
• 00840343716622: Chest Pad: Memory foam cushion used in conjunction with positioning device to provide comfort an
• 00840343716615: Supine Platform: removable solid carbon fiber platform with locking mechanism. Designed to be us
• 00840343716813: Traction Mounting Plate Assembly- mounting plate for FusionMAX Rope Traction Assembly. Secures t
• 00840343716776: Rope Traction Assembly- metal pulley device designed to be used in cervical spine procedures. To
• 00840343716769: Leg Sling- vinyl fabric sling that attached to surgical table. Designed to support lower body du
• 00840343716752: Thigh Pad- cushion designed to support the thigh area during surgical procedures. Individual spa
• 00840343716738: Ball Swivel Adjustable Arm Board- adjustable arm board for use with surgical table. Provides sup
• 00840343716721: Safety Strap- heavy duty strap designed to secure patient to surgical table during procedures
• 00840343716714: FlexFrame- Patient supoort device. Designed to support and position torso in prone position. Two
• 00840343716707: Accessory Rail- moveable side rail for surgical table. Adjustable to full length of table by use
• 00840343716691: Ankle Support Pad- cushion designed to support and elevate the ankle area during surgical proced
• 00840343716660: FusionMAX Head Rest Support- plastic headrest for prone positioning. Designed to be used in conj
• 00840343716653: Head Support Tray-plastic head support for use in prone procedures. press fit to head of surgica
• 10840343716827: Disposable cover kit - Case of 10 - UDI issued by FDA
• 00840343723156: PLEXIGLASS HEAD SUPPORT TRAY, NON-ADJUSTABLE
• 00840343717599: Foot/Ankle Pad Cover
• 00840343717582: Knee Pad Cover
• 00840343717575: Foam Bar Cushion
• 00840343717568: Foam Pelvic Board Pad
• 00840343717551: Hip/Thigh Pad Cover
• 00840343717544: Chest Pad Cover
• 00840343716820: Disposable cover kit
• 00840343725327: Flex Frame Disposables Covers Kit - 2 fabric pad covers & 2 foam bar covers. Case of 20