Dover Headlight System

GUDID 00851610007343

Light, Surgical, Endoscopic, Accessory

LONG ISLAND TECH

Head-worn lamp

• Primary Device ID: 00851610007343
• NIH Device Record Key: b5b55627-70de-4227-88e1-946a8bbeff21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dover Headlight System
• Version Model Number: P002500
• Company DUNS: 030256600
• Company Name: LONG ISLAND TECH
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 86 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851610007343 [Primary]

FDA Product Code

• KYT: Light, Examination, Medical, Battery Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

Devices Manufactured by LONG ISLAND TECH

• 00851610007220 - Pharos HD Headcam: 2021-06-15 Surgical Camera & Light
• 00851610007299 - Fiji Headband: 2021-06-15 Surgical Headlight Accessory
• 00851610007336 - Pharos HD CCU: 2021-06-15 Surgical Camera & Light
• 00851610007190 - Dover Headlight Optic: 2020-12-29 Light, Surgical, Accessory
• 00851610007206 - Bristol Headlight Optic: 2020-12-29 Light, Surgical, Accessory
• 00851610007213 - Daymark Headlight Optic: 2020-12-29 Light, Surgical, Accessory
• 00851610007268 - Dover Holster: 2020-12-29
• 00851610007275 - Bristol Holster: 2020-12-29 Light & Surgical Accessory