LD-I 200 Treatment Head

GUDID B271LDI2000

Meditech International Inc

Red-light phototherapy unit, line-powered

• Primary Device ID: B271LDI2000
• NIH Device Record Key: a42e973a-4a7a-45f1-b952-1df9a83d540a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LD-I 200 Treatment Head
• Version Model Number: LD-I 200
• Company DUNS: 255079485
• Company Name: Meditech International Inc
• 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
HIBCC	B271LDI2000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041885

FDA Product Code

• NHN: Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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: 2016-08-09

On-Brand Devices [LD-I 200 Treatment Head]

• B271LDI200P0: LD-I 200 Treatment Head
• B271LDI2000: LD-I 200