| 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 |
| 00615375008591 - Orascoptic - Orascoptic - HDL 2.5 Macro Rx | 2024-08-16NA |
| 00615375008591 - Orascoptic - Orascoptic - HDL 2.5 Macro Rx | 2024-08-16 NA |
| 00615375009987 - Orascoptic - HDL 2.5 Macro | 2024-08-16 NA |
| 10615375012861 - CaviWipes HP | 2024-01-31 CaviWipes HP Surface Disinfecting Wipes 160 Pre-Saturated Towelettes (6" x 6.75" | 15.24 cm x 17.15 cm). |
| 10615375012885 - CaviWipes HP | 2024-01-31 CaviWipes HP Extra Large Surface Disinfecting Wipes, "12 x 65 Pre-Saturated Extra Large Towelettes (9"" x 12"" | 22.86 cm x 30.4 |
| 00615375013335 - Endeavour MD | 2023-11-21 FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, NORTH AMERICA, TTL |
| 00615375013342 - Endeavour MD | 2023-11-21 FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, NORTH AMERICA, UNIVERSAL |
| 00615375013359 - Endeavour MD | 2023-11-21 FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, NORTH AMERICA, JAW |
| 00615375013366 - Endeavour MD | 2023-11-21 FINAL ASSEMBLY, ENDEAVOUR™ MD, SINGLE, INTERNATIONAL, TTL |