Endeavour™ TruColor™

GUDID 00615375013540

Endeavour™ TruColor™ headlight system - North America, FU1

METREX RESEARCH, LLC

General-purpose light source

• Primary Device ID: 00615375013540
• NIH Device Record Key: 29b155f4-5e84-4d29-8915-b000c3291bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endeavour™ TruColor™
• Version Model Number: 910177-2
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, 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: 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

Customer Support Contacts

• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com
• Phone: 1.800.369.3698
• Email: CustomerCare@Orascoptic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)
• Special Storage Condition, Specify: Between 0 and 0 *Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to 1.0 atm (500 hPa to 1060 hPa)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375013540 [Primary]

FDA Product Code

• EBA: Light, Surgical Headlight

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: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [Endeavour™ TruColor™]

• 00850036373759: Endeavour™ TruColor™ battery pack replacement kit
• 00615375013564: Endeavour™ TruColor™ headlight system - North America, GSC
• 00615375013557: Endeavour™ TruColor™ headlight system - North America, FU2
• 00615375013540: Endeavour™ TruColor™ headlight system - North America, FU1
• 00615375013533: Endeavour™ TruColor™ headlight system - North America, TTL