Primary Device ID | 06971381250114 |
NIH Device Record Key | 28f7235d-50da-4901-8fa0-9e52cb87312c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LED Light Source |
Version Model Number | ES-LS110D |
Company DUNS | 544519831 |
Company Name | SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
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 | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | 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 |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06971381250114 [Primary] |
NTN | Led Light Source |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-25 |
Device Publish Date | 2023-05-17 |
06971381251357 - Insufflator | 2024-03-07 The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to provide visual field and operat |
06971381251364 - Insufflator | 2024-03-07 The insufflator is intended to form and maintain the pneumoperitoneum in laparoscopic surgery to provide visual field and operat |
16971381253143 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253150 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253167 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253174 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253181 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
16971381253198 - Single-use Biopsy Forceps | 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LED LIGHT SOURCE 79200359 5243529 Live/Registered |
Maxell Holdings, Ltd. 2016-09-01 |