Sunoptic Technologies

GUDID M678SLS10

LED Rover Disoposable, Non-Sterile Series

SUNOPTIC TECHNOLOGIES LLC

Hand-held examination/treatment light

• Primary Device ID: M678SLS10
• NIH Device Record Key: ec60aad5-70f8-42ed-bbae-b85c9e9eaf06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunoptic Technologies
• Version Model Number: Rover Lightsource series
• Company DUNS: 094586898
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com
• Phone: 904 737-7611
• Email: robert.archie@sunoptictech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M678SLS0 [Primary]
HIBCC	M678SLS10 [Package]; Contains: M678SLS0; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• FCW: Light Source, Fiberoptic, Routine

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: 2024-08-14
• Device Publish Date: 2018-06-27

On-Brand Devices [Sunoptic Technologies]

• M678WCS0: Wireless Camera System
• M678TITAN0: Xenon Lightsource
• M678FOC0: fiberoptic cables
• M678LED90000: LED 9000 headlight series
• M678HLC0: Fiberoptic Cables for headlight
• M678HLM0: headlights molded
• M678HL0: headlights
• M678CS0: camera systems
• M678SLS10: LED Rover Disoposable, Non-Sterile Series
• M678ROVER0: Rover lightsource series
• M678DLS10: LED Rover Disoposable Series