| Primary Device ID | 04064434000087 |
| NIH Device Record Key | 4cfdf594-a1cc-4d6d-a98a-64febb5cf008 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeeLuma Re-Sterilizable Caps |
| Version Model Number | V10062-01 |
| Company DUNS | 315155571 |
| Company Name | Munich Surgical Imaging GmbH |
| Device Count | 12 |
| 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 | true |
| Serial Number | false |
| 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 |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04064434000056 [Primary] |
| GS1 | 04064434000087 [Unit of Use] |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
[04064434000087]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-11 |
| Device Publish Date | 2023-04-03 |
| 04064434000124 - SeeLuma | 2024-06-03 The medical device is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic s |
| 04064434000148 - SeeLuma Digital Binoculars Module | 2024-06-03 SeeLuma Digital Binoculars Module is an accessory for the surgical microscope SeeLuma. |
| 04064434000155 - SeeLuma Digital Binoculars Upgrade Kit | 2024-06-03 SeeLuma Digital Binoculars Upgrade Kit is an accessory for the surgical microscope SeeLuma. |
| 04064434000087 - SeeLuma Re-Sterilizable Caps | 2023-04-11SeeLuma Re-Sterilizable Caps are accessories to the surgical microscope SeeLuma. |
| 04064434000087 - SeeLuma Re-Sterilizable Caps | 2023-04-11 SeeLuma Re-Sterilizable Caps are accessories to the surgical microscope SeeLuma. |
| 04064434000063 - SeeLuma Binoculars | 2023-04-11 SeeLuma Binoculars are accessories to the surgical microscope SeeLuma. |
| 04064434000070 - SeeLuma Laserfilter 532nm | 2023-04-11 SeeLuma Laserfilter 532nm is an accessory to the surgical microscope SeeLuma. |
| 04064434000117 - SeeLuma | 2023-04-03 The ophthalmic microscope is a surgical microscope designed for the illumination and magnification of the surgical area in ophth |