Primary Device ID | 00850036373926 |
NIH Device Record Key | 1954c5ea-7644-40ff-91e1-177717485b82 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ErgoZoom™ Plano - Dragonfly™ |
Version Model Number | .ERGOZOOM.TTL.DRAGONFLY * (GEN 2).*, 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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00850036373926 [Primary] |
FSP | Loupe, Diagnostic/Surgical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-29 |
Device Publish Date | 2025-07-21 |
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™ | 2025-07-29Dragonfly™ Powered Loupe with ErgoZoom™ Plano 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 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ERGOZOOM 98574854 not registered Live/Pending |
Metrex Research, LLC 2024-05-29 |