ErgoZoom™ Rx - Dragonfly™

GUDID 00850036373933

Dragonfly™ Powered Loupe with ErgoZoom™ Prescription Oculars

METREX RESEARCH, LLC

Surgical binoculars, reusable

• Primary Device ID: 00850036373933
• NIH Device Record Key: 3731b4b0-1371-490e-8f4b-ed0967443379
• Commercial Distribution Discontinuation: 2025-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ErgoZoom™ Rx - Dragonfly™
• Version Model Number: .ERGOZOOM.TTL.DRAGONFLY * (GEN 2).*, Rx
• 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: true
• 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

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)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850036373933 [Primary]

FDA Product Code

• FSP: Loupe, Diagnostic/Surgical

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: 2025-07-29
• Device Publish Date: 2025-07-21

Devices Manufactured by METREX RESEARCH, LLC

• 00810210820004 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - International, Type I plug
• 00810210820011 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - China, Type A plug
• 00810210820028 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - North America, Type A plug
• 00810210820035 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - International, Type A plug
• 00810210820042 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - International, Type C plug
• 00810210820059 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - International, Type G plug
• 00810210820066 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - International, Type I plug
• 00810210820073 - Spark™ TruColor™: 2025-12-17 Spark™ TruColor™ headlight system - North America, Type A plug