| Primary Device ID | 07630003590401 |
| NIH Device Record Key | 9afd9ef1-f8f3-4f45-8e3a-127e98e8f1a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leica GLOW800 |
| Version Model Number | 000000000010448962 |
| Company DUNS | 480198725 |
| Company Name | Leica Microsystems (Schweiz) AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | +1(847)8213462 |
| adam.blunier@leica-microsystem |
| Device Size Text, specify | 0 |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Handling Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630003590401 [Primary] |
| IZI | System, x-ray, angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
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| 07630802403827 - MyVeo Headset | 2024-05-10 MyVeo Headset - additional Headset to MyVeo Connection Hub |
| 07630003567717 - RUV800 WD175 | 2022-08-29 RUV800 WD175 - Accessory for Leica surgical operating microscope systems |
| 07630003567724 - Leica RUV800 WD200 | 2022-08-29 RUV800 WD200 - Accessory for Leica surgical operating microscope systems |
| 07630003599008 - PROVEO 8 F42 | 2022-04-08 PROVEO 8 Stand F42, OCT Ready variant - for Leica surgical operating microscope system: PROVEO 8 |