Sunoptic Technologies

GUDID M678TX0

Tx series Xenon Lightsource

SUNOPTIC TECHNOLOGIES LLC

General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source

• Primary Device ID: M678TX0
• NIH Device Record Key: db153b01-d736-476f-9acb-e128a7ee8dbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunoptic Technologies
• Version Model Number: Tx series Xenon Lightsource
• 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: false
• Lot Batch: true
• 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

Customer Support Contacts

• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com
• Phone: 9047377611
• Email: janice.lee@sunoptictech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M678TX0 [Primary]

FDA Product Code

• FSS: Light, Surgical, Floor Standing

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: 2023-08-08
• Device Publish Date: 2017-05-09

Devices Manufactured by SUNOPTIC TECHNOLOGIES LLC

• M678CS0 - Sunoptic Technologies: 2023-10-11 camera systems
• M678HL0 - Sunoptic Technologies: 2023-10-11 headlights
• M678HLM0 - Sunoptic Technologies: 2023-10-11 headlights molded
• M678TLCSLS0 - TracLux: 2023-09-28 TracLux SLS-S, Battery Operated Lightsource
• M678TX0 - Sunoptic Technologies: 2023-08-08Tx series Xenon Lightsource
• M678TX0 - Sunoptic Technologies: 2023-08-08 Tx series Xenon Lightsource
• M678HLC0 - Sunoptic Technologies: 2023-06-14 Fiberoptic Cables for headlight
• M678LED90000 - Sunoptic Technologies: 2023-06-13 LED 9000 headlight series
• M678DPLS400W0 - Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer: 2023-03-09 Xenon Lightsource, 400 Watt, Digital