Primary Device ID | 00860001744293 |
NIH Device Record Key | 18ea6567-6bbe-42e3-aa67-40aadf8e9139 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lazurite Holdings LLC ArthroFree Sterilization Tray Kit |
Version Model Number | AF0030-101-10 |
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 | |
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 | |
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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 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 *Long Term Storage, between -20 and 20 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 10 and 75 percent relative humidity |
Handling Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Long Term Storage, between 70 and 106 Kilopascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860001744293 [Primary] |
GCJ | Laparoscope, general & plastic surgery |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
[00860001744293]
Hydrogen Peroxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-22 |
Device Publish Date | 2022-09-14 |
00860001744293 | AF0030-101-10 |
00850045863005 | AF0030-101-10 |