Primary Device ID | 8809447651415 |
NIH Device Record Key | 23aaba21-6d21-4613-b47e-2a125bc4cda7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CLARITY |
Version Model Number | CLARITY-LPC, ICD 1.5 body |
Company DUNS | 688282516 |
Company Name | Lutronic Corporation |
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 | 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 |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |