810nm 200mW Standard Tip

GUDID 05060494130220

S2092 810nm 200mW Standard Tip

THOR PHOTOMEDICINE LIMITED

Red-light phototherapy unit, line-powered

• Primary Device ID: 05060494130220
• NIH Device Record Key: 2b18a259-6c77-4eed-b409-388bdd9a2e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 810nm 200mW Standard Tip
• Version Model Number: 2.3
• Company DUNS: 856233908
• Company Name: THOR PHOTOMEDICINE LIMITED
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060494130220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033923

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: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [810nm 200mW Standard Tip]

• 05060494130220: S2092 810nm 200mW Standard Tip
• 05060494130213: S1092 810nm 200mW Standard Tip