Lazurite Holdings LLC Receiver

GUDID 00860001744248

Lazurite Holdings LLC

Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system 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