ProFlex™ R-LLF550-T-USL

GUDID 00816959021719

INNOVAQUARTZ LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00816959021719
• NIH Device Record Key: 43365a30-be46-4f0b-ab49-e3aeb7a44a59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFlex™
• Version Model Number: 550 Reusable Laser Lithotripsy Fiber var. Trimedyn
• Catalog Number: R-LLF550-T-USL
• 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: false
• 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@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816959021719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180140

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00816959021719]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-26
• Device Publish Date: 2020-08-18

On-Brand Devices [ProFlex™]

• 00816959020668: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020651: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020644: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020637: Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm.
• 00816959020620: Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
• 00816959020613: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020606: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020590: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020583: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020576: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020569: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020552: Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm.
• 00816959020545: Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm.
• 00816959020538: Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
• 00816959020521: Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
• 00816959020514: Maximum Power (J x PPS): 10W. Wavelengths Range: 500nm to 2200nm.
• 00816959020507: Maximum Power (J x PPS): 10W. Wavelengths Range: 500nm to 2200nm.
• 00816959020491: Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
• 00816959020484: Laser Lithotripsy Fiber
• 00816959020477: Laser Lithotripsy Fiber
• 00816959020460: Laser Lithotripsy Fiber
• 00816959020453: Laser Lithotripsy Fiber
• 00816959020446: Laser Lithotripsy Fiber
• 00816959020439: Laser Lithotripsy Fiber
• 00816959020422: Laser Lithotripsy Fiber
• 00816959020415: Laser Lithotripsy Fiber
• 00816959020408: Laser Lithotripsy Fiber
• 00816959020392: Laser Lithotripsy Fiber
• 00816959020385: Laser Lithotripsy Fiber
• 00816959020378: Laser Lithotripsy Fiber
• 00816959020361: Laser Lithotripsy Fiber
• 00816959020354: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod
• 00816959020347: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod
• 00816959020330: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod
• 00816959020323: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod
• 00816959020316: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ
• 00816959020309: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ
• 00816959020293: Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ
• 00816959020286: Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ
• 00816959020279: Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produc
• 00816959020262: Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Produ
• 00816959020255: Laser Lithotripsy Fiber
• 00816959020248: Laser Lithotripsy Fiber
• 00816959020231: Laser Lithotripsy Fiber
• 00816959020224: Laser Lithotripsy Fiber
• 00816959020217: Laser Lithotripsy Fiber
• 00816959020200: Laser Lithotripsy Fiber
• 00816959020194: Laser Lithotripsy Fiber
• 00816959020187: Laser Lithotripsy Fiber
• 00816959020170: Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Prod