| Primary Device ID | 10860001744221 |
| NIH Device Record Key | 9c4581e4-ae7b-40b5-9930-c527028d8c99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lazurite Holdings LLC ArthroFree Battery Set |
| Version Model Number | AF0015-101-10 |
| Company DUNS | 088448366 |
| Company Name | Lazurite Holdings LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | +1(833)214-2324 |
| danielle@lazurite.co | |
| Phone | +1(833)214-2324 |
| danielle@lazurite.co | |
| Phone | +1(833)214-2324 |
| danielle@lazurite.co | |
| Phone | +1(833)214-2324 |
| danielle@lazurite.co | |
| Phone | +1(833)214-2324 |
| danielle@lazurite.co | |
| Phone | +1(833)214-2324 |
| danielle@lazurite.co | |
| Phone | +1(833)214-2324 |
| danielle@lazurite.co |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 30 and 75 percent Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 10 and 75 percent relative humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, Between -20 and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between -20 and 20 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
| Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10860001744221 [Primary] |
| GCJ | Laparoscope, general & plastic surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10860001744221]
Hydrogen Peroxide
[10860001744221]
Hydrogen Peroxide
[10860001744221]
Hydrogen Peroxide
[10860001744221]
Hydrogen Peroxide
[10860001744221]
Hydrogen Peroxide
[10860001744221]
Hydrogen Peroxide
[10860001744221]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-13 |
| Device Publish Date | 2022-06-05 |