TerraQuant 850-113

GUDID 00852556007145

Multi Radiance Medical

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00852556007145
• NIH Device Record Key: e3394edb-c52d-4307-9ce4-4c4eed5732b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TerraQuant
• Version Model Number: TQ SE25 Standard Emitter
• Catalog Number: 850-113
• 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	00852556007145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061614

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [TerraQuant]

• 00852556007268: TQ Solo Laser
• 00852556007152: TQ LaserShower 50 4-D Emitter
• 00852556007145: TQ SE25 Standard Emitter
• 00852556007138: TQ LaserStim Emitter
• 00852556007121: TerraQuant Super Pulsed Laser Console
• 00852556007114: TerraQuant Laser System
• 00852556007084: TQ Solo Laser