MegaJOULE LDD™ MJLDD660

GUDID 00816959021627

INNOVAQUARTZ LLC

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00816959021627
• NIH Device Record Key: 93e8c345-4c15-4100-b083-e4decbabe35c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaJOULE LDD™
• Version Model Number: MegaJOULE Lateral Delivery Device 660
• Catalog Number: MJLDD660
• Company DUNS: 079295103
• Company Name: INNOVAQUARTZ 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com
• Phone: 844-776-3539
• Email: info@innovaquartz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816959021627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050412

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-30
• Device Publish Date: 2021-07-22

Devices Manufactured by INNOVAQUARTZ LLC

• 00816959021627 - MegaJOULE LDD™: 2021-07-30
• 00816959021627 - MegaJOULE LDD™: 2021-07-30
• 00816959021672 - ProFlex™: 2020-08-26
• 00816959021696 - ProFlex™: 2020-08-26
• 00816959021719 - ProFlex™: 2020-08-26
• 00816959021733 - ProFlex™: 2020-08-26
• 00816959021634 - ProFlex™: 2020-08-25
• 00816959021641 - ProFlex™: 2020-08-25
• 00816959021658 - ProFlex™: 2020-08-25