Primary Device ID | 16971381250166 |
NIH Device Record Key | b62d245a-4731-45a0-a028-95c86e8a43f1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 4K UHD Laparoscope |
Version Model Number | 4K5500 |
Company DUNS | 544519831 |
Company Name | SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
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 | false |
OTC Over-The-Counter | false |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Temperature | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Atmospheric Pressure | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between -40 Degrees Celsius and 55 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06971381250169 [Primary] |
GS1 | 16971381250166 [Package] Contains: 06971381250169 Package: [2 Units] In Commercial Distribution |
HET | Laparoscope, Gynecologic (And Accessories) |
Steralize Prior To Use | true |
Device Is Sterile | false |
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
[16971381250166]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-25 |
Device Publish Date | 2023-05-17 |
16971381250272 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250265 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250258 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250241 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250234 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250227 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250210 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250203 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250197 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250180 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
06971381250176 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |
16971381250166 | These endoscopes are intended to be used for endoscopy and endoscopic surgery within the thoraci |