MR4 650-114

GUDID 00852556007053

Multi Radiance Medical

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00852556007053
• NIH Device Record Key: 440ee6c9-7e08-487d-b08a-069585fb12ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR4
• Version Model Number: MR4 LaserShower 50 4-D Emitter
• Catalog Number: 650-114
• 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	00852556007053 [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 [MR4]

• 00852556007220: MR4 LaserShower 50 4-D Emitter G
• 00852556007213: MR4 LaserStim Emitter G
• 00852556007206: MR4 Super Pulsed Laser Console G
• 00852556007183: MR4 Activ G
• 00852556007176: MR4 Laser System G
• 00852556007077: MR4 Activ
• 00852556007060: MR4 LaserShower 50 6-D Emitter
• 00852556007053: MR4 LaserShower 50 4-D Emitter
• 00852556007046: MR4 SE25 Standard Emitter
• 00852556007039: MR4 LaserStim Emitter
• 00852556007022: MR4 Super Pulsed Laser Console
• 00852556007015: MR4 Laser System