GameDay U300-200

GUDID 00852556007107

Multi Radiance Medical

Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00852556007107
• NIH Device Record Key: 1ce8b98d-7624-4dad-97bd-a2953d6a11f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GameDay
• Version Model Number: Gameday Laser
• Catalog Number: U300-200
• Company DUNS: 826320694
• Company Name: Multi Radiance Medical
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852556007107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080102

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-08
• Device Publish Date: 2016-09-23

On-Brand Devices [GameDay]

• 00852556007190: Gameday Laser G
• 00852556007107: Gameday Laser
• 00852556007367: Gameday Laser
• 00852556007350: Gameday Laser