Spark™ TruColor™

GUDID 00810210820127

Spark™ TruColor™ headlight system - China, Type A plug

METREX RESEARCH, LLC

General-purpose light source

• Primary Device ID: 00810210820127
• NIH Device Record Key: 5152229b-1484-4682-bd5b-a0d162c96dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spark™ TruColor™
• Version Model Number: 910190-6
• 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

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)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810210820127 [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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [Spark™ TruColor™]

• 00850036373995: Spark™ TruColor™ headlight system - International, Type G plug
• 00850036373988: Spark™ TruColor™ headlight system - International, Type C plug
• 00850036373971: Spark™ TruColor™ headlight system - International, Type A plug
• 00850036373964: Spark™ TruColor™ headlight system - North America, Type A plug
• 00810210820172: Spark™ TruColor™ headlight system - International, Type I plug
• 00810210820165: Spark™ TruColor™ headlight system - International, Type G plug
• 00810210820158: Spark™ TruColor™ headlight system - International, Type C plug
• 00810210820141: Spark™ TruColor™ headlight system - International, Type A plug
• 00810210820134: Spark™ TruColor™ headlight system - North America, Type A plug
• 00810210820127: Spark™ TruColor™ headlight system - China, Type A plug
• 00810210820110: Spark™ TruColor™ headlight system - International, Type I plug
• 00810210820103: Spark™ TruColor™ headlight system - International, Type G plug
• 00810210820097: Spark™ TruColor™ headlight system - International, Type C plug
• 00810210820080: Spark™ TruColor™ headlight system - International, Type A plug
• 00810210820073: Spark™ TruColor™ headlight system - North America, Type A plug
• 00810210820066: Spark™ TruColor™ headlight system - International, Type I plug
• 00810210820059: Spark™ TruColor™ headlight system - International, Type G plug
• 00810210820042: Spark™ TruColor™ headlight system - International, Type C plug
• 00810210820035: Spark™ TruColor™ headlight system - International, Type A plug
• 00810210820028: Spark™ TruColor™ headlight system - North America, Type A plug
• 00810210820011: Spark™ TruColor™ headlight system - China, Type A plug
• 00810210820004: Spark™ TruColor™ headlight system - International, Type I plug