Professional System Main Controller Unit

GUDID B271MCU0

Meditech International Inc

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• Primary Device ID: B271MCU0
• NIH Device Record Key: 7091c243-4756-4686-88e5-d9b00837cedf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Professional System Main Controller Unit
• Version Model Number: MCU
• 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	B271MCU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023621

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

Devices Manufactured by Meditech International Inc

• B271MCUI0 - MiniPort Main Controller Unit: 2023-10-10
• B271ART1800 - ART180: 2023-09-26
• B271CUPA0 - Arthritis Controller Unit: 2023-09-26
• B271CU0 - CU Controller: 2018-07-06
• B271CUP0 - CU+ Controller: 2018-07-06
• B271DUO1800 - DUO+ 180 Treatment Head: 2018-07-06
• B271DUO2400 - DUO+ 240 Treatment Head: 2018-07-06
• B271LDI2000 - LD-I 200 Treatment Head: 2018-07-06