| Primary Device ID | 00615375008591 |
| NIH Device Record Key | 62c56658-06bc-49a1-98f4-6d5be05c06f8 |
| Commercial Distribution Discontinuation | 2022-12-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Orascoptic - Orascoptic - HDL 2.5 Macro Rx |
| Version Model Number | HDL 2.5 Macro 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm |
| 00850036373469 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes:
Model No. DI Number Device Description
922537-1 00850036373377 |
| 00850036373483 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, near PD, regular WD |
| 00850036373490 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, near PD, long WD |
| 00850036373506 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, regular PD, short WD |
| 00850036373513 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, regular PD, regular WD |
| 00850036373520 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, regular PD, long WD |
| 00850036373537 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, wide PD, short WD |
| 00850036373544 - Luxe™ 2.5 Semi-custom loupe | 2024-09-20 Semi-custom loupe with Luxe™ 2.5 plano oculars, Tempo Refined Fit amethyst frame, wide PD, regular WD |