Luxe™ 2.5 Semi-custom loupe

GUDID 00850036373582

Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, near PD, long WD

METREX RESEARCH, LLC

Surgical binoculars, reusable

• Primary Device ID: 00850036373582
• NIH Device Record Key: 61c162aa-a509-4dd5-9738-3683dfbdffc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luxe™ 2.5 Semi-custom loupe
• Version Model Number: 910168-3
• 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	00850036373582 [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: 2024-09-20
• Device Publish Date: 2024-09-12

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• 00850036373704: Semi-custom loupe with Luxe™ 2.5 plano oculars, Phantom black frame, regular PD, long WD
• 00850036373698: Semi-custom loupe with Luxe™ 2.5 plano oculars, Phantom black frame, regular PD, regular WD
• 00850036373681: Semi-custom loupe with Luxe™ 2.5 plano oculars, Phantom black frame, regular PD, short WD
• 00850036373674: Semi-custom loupe with Luxe™ 2.5 plano oculars, Phantom black frame, near PD, long WD
• 00850036373667: Semi-custom loupe with Luxe™ 2.5 plano oculars, Phantom black frame, near PD, regular WD
• 00850036373650: Semi-custom loupe with Luxe™ 2.5 plano oculars, Phantom black frame, near PD, short WD
• 00850036373643: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, wide PD, long W
• 00850036373636: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, wide PD, regula
• 00850036373629: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, wide PD, short
• 00850036373612: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, regular PD, lon
• 00850036373605: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, regular PD, reg
• 00850036373599: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, regular PD, sho
• 00850036373582: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, near PD, long W
• 00850036373575: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, near PD, regula
• 00850036373568: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit slate frame, near PD, short
• 00850036373551: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, wide PD, lon
• 00850036373544: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, wide PD, reg
• 00850036373537: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, wide PD, sho
• 00850036373520: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, regular PD,
• 00850036373513: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, regular PD,
• 00850036373506: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, regular PD,
• 00850036373490: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, near PD, lon
• 00850036373483: Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, near PD, reg
• 00850036373469: Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes: Model No. DI Number Device Descrip