Viseon Image Control Box

GUDID 00850007069254

Image Control Box - For use with the MaxView™ System devices.

VISEON, INC.

Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system Spinal endoscopic-access system

• Primary Device ID: 00850007069254
• NIH Device Record Key: 26237767-8bd5-4af4-95b3-8e067a2569a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viseon Image Control Box
• Version Model Number: ICB-02
• Company DUNS: 096680671
• Company Name: VISEON, INC.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com
• Phone: 949-662-3959
• Email: customerservice@viseon-spine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007069254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191579

FDA Product Code

• HRX: Arthroscope

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: 2021-11-23
• Device Publish Date: 2021-11-15

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• 00850007069445 - Image Control Box: 2024-02-13 Image Control Box (ICB-4K)
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