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) |