| Primary Device ID | 10615375009595 |
| NIH Device Record Key | dd0f24ff-0486-4d1c-827c-1d1bd2f8f58f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orascoptic - OmniOpti HDL 2.5 |
| Version Model Number | OmniOpti HDL 2.5 |
| 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 |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com | |
| Phone | +18003693698 |
| CustomerCare@orascoptic.com |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10615375009595 [Primary] |
| FSP | LOUPE, DIAGNOSTIC/SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-04-25 |
| Device Publish Date | 2022-12-08 |
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