Lazurite Holdings LLC Receiver

GUDID 00860001744248

Lazurite Holdings LLC

Video camera surgical microscope system

• Primary Device ID: 00860001744248
• NIH Device Record Key: 7511efcc-c318-453b-b318-5172b49b2e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lazurite Holdings LLC Receiver
• Version Model Number: AF0002-101-10
• 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: false
• 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

Customer Support Contacts

• Phone: +1(833)214-2324
• Email: danielle@lazurite.co
• Phone: +1(833)214-2324
• Email: danielle@lazurite.co
• Phone: +1(833)214-2324
• Email: danielle@lazurite.co
• Phone: +1(833)214-2324
• Email: danielle@lazurite.co
• Phone: +1(833)214-2324
• Email: danielle@lazurite.co
• Phone: +1(833)214-2324
• Email: danielle@lazurite.co
• Phone: +1(833)214-2324
• Email: danielle@lazurite.co

Operating and Storage Conditions

• 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 *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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius 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 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
• 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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius 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 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
• 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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius 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 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
• 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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius 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 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
• 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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius 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 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
• 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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius 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 *Short Storage and Transport, Between -20 and 30 Degrees Celsius
• 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
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal 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 *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
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Short Storage and Transport, between 50 and 106 Kilopascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001744248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213860

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-13
• Device Publish Date: 2022-06-05

Devices Manufactured by Lazurite Holdings LLC

• 00850045863005 - Lazurite Holdings LLC ArthroFree Sterilization Tray Kit: 2022-09-22
• 00860001744279 - Lazurite Holdings LLC ArthroFree Receiver Kit: 2022-09-22
• 00860001744286 - Lazurite Holdings LLC ArthroFree Battery Charger Kit: 2022-09-22
• 00860001744293 - Lazurite Holdings LLC ArthroFree Sterilization Tray Kit: 2022-09-22
• 00860001744200 - Lazurite Holdings LLC Wireless Camera Head: 2022-06-13
• 00860001744217 - Lazurite Holdings LLC Sterilization Tray: 2022-06-13
• 00860001744224 - Lazurite Holdings LLC Battery: 2022-06-13
• 00860001744231 - Lazurite Holdings LLC Battery Charger: 2022-06-13