| Primary Device ID | 10841736114985 |
| NIH Device Record Key | 08eb939e-399e-4756-b382-a0dce295e040 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skytron DoVera Positioning Handle |
| Version Model Number | 1950288 |
| Company DUNS | 078375583 |
| Company Name | SKYTRON 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 | false |
| Manufacturing Date | false |
| 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 | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us | |
| Phone | 800-759-8766 |
| info@skytron.us |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841736114985 [Primary] |
| FSY | Light, Surgical, Ceiling Mounted |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
[10841736114985]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2018-10-31 |
| 10841736114978 | Skytron DoVera Positioning Handle (Camera Light Head) |
| 10841736114961 | Skytron DoVera Positioning Handle (non Camera Light Head) |
| 10841736114985 | Skytron DoVera Positioning Handle (Camera Cover Handle) |