ErgoZoom™ Plano

GUDID 00850036373902

Loupe with ErgoZoom™ Plano Oculars

METREX RESEARCH, LLC

Surgical binoculars, reusable

• Primary Device ID: 00850036373902
• NIH Device Record Key: 664b3a22-6d17-40bf-a41c-8295c52714e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ErgoZoom™ Plano
• Version Model Number: .ERGOZOOM.TTL.*, Plano
• 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

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	00850036373902 [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

• 00850036373902 - ErgoZoom™ Plano: 2025-07-29Loupe with ErgoZoom™ Plano Oculars
• 00850036373902 - ErgoZoom™ Plano: 2025-07-29 Loupe with ErgoZoom™ Plano Oculars
• 00850036373919 - ErgoZoom™ Rx: 2025-07-29 Loupe with ErgoZoom™ Prescription Oculars
• 00850036373926 - ErgoZoom™ Plano - Dragonfly™: 2025-07-29 Dragonfly™ Powered Loupe with ErgoZoom™ Plano Oculars
• 00850036373933 - ErgoZoom™ Rx - Dragonfly™: 2025-07-29 Dragonfly™ Powered Loupe with ErgoZoom™ Prescription Oculars
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• 00615375010129 - Universal Flip - Plano: 2025-05-08 Universal Flip loupe with plano lenses
• 00615375010136 - Universal Flip - Rx: 2025-05-08 Universal Flip loupe with prescription lenses
• 00615375013533 - Endeavour™ TruColor™: 2025-05-08 Endeavour™ TruColor™ headlight system - North America, TTL