TruDenta U801

GUDID 00852556007169

Multi Radiance Medical

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00852556007169
• NIH Device Record Key: d5bfe684-ec71-4618-bb4a-b60668647a32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruDenta
• Version Model Number: TruDenta Laser System
• Catalog Number: U801
• 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: false
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852556007169 [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

Devices Manufactured by Multi Radiance Medical

• 00852556007350 - GameDay: 2023-08-02
• 00852556007367 - GameDay: 2023-08-02
• 00852556007008 - FibroLux: 2022-11-16
• 00852556007336 - PainAway: 2021-09-15
• 00852556007343 - PainAway: 2021-09-15
• 00852556007305 - MR5: 2020-09-07
• 00852556007312 - MR5: 2020-09-07
• 00852556007329 - MR5: 2020-09-07