LD-R 100 Treatment Head

GUDID B271LDR100P0

LD-R 100 Treatment Head

Meditech International Inc

Red-light phototherapy unit, line-powered

• Primary Device ID: B271LDR100P0
• NIH Device Record Key: 6165d90b-6384-4322-9f25-5fb8842b7f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LD-R 100 Treatment Head
• Version Model Number: LD-R 100+
• Company DUNS: 255079485
• Company Name: Meditech International Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B271LDR100P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081355

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-01

On-Brand Devices [LD-R 100 Treatment Head]

• B271LDR100P0: LD-R 100 Treatment Head
• B271LDR1000: LD-R 100