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 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| CustomerCare@Orascoptic.com | |
| Phone | 1.800.369.3698 |
| 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
| 10615375013455 - CaviCide HP | 2025-08-12 Ready-to-Use Hard Surface Disinfectant |
| 10615375013479 - CaviCide HP | 2025-08-12 Ready-to-Use Hard Surface Disinfectant |
| 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 |
| 00615375009543 - Endeavour™ XL | 2025-05-08 Endeavour™ XL Headlight System - Kavo China, TTL |
| 00615375010129 - Universal Flip - Plano | 2025-05-08 Universal Flip loupe with plano lenses |
Trademark Results [ErgoZoom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERGOZOOM 98574854 not registered Live/Pending |
Metrex Research, LLC 2024-05-29 |
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