ProFlex™ R-LLF200TG-T-USL

GUDID 00816959021641

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 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 ID00816959021641
NIH Device Record Keye7f4ad35-c921-4b90-b70f-11f7febd9b63
Commercial Distribution StatusIn Commercial Distribution
Brand NameProFlex™
Version Model Number200 Reusable Laser Lithotripsy Fiber var. Trimedyn
Catalog NumberR-LLF200TG-T-USL
Company DUNS079295103
Company NameINNOVAQUARTZ LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com
Phone844-776-3539
Emailinfo@proflexfibers.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816959021641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00816959021641]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-25
Device Publish Date2020-08-17

On-Brand Devices [ProFlex™]

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

Trademark Results [ProFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFLEX
PROFLEX
98480005 not registered Live/Pending
Texas Road Recyclers, LLC
2024-04-02
PROFLEX
PROFLEX
98375844 not registered Live/Pending
John Bean Technologies Corporation
2024-01-25
PROFLEX
PROFLEX
98074834 not registered Live/Pending
Textron Aviation Inc.
2023-07-07
PROFLEX
PROFLEX
98003344 not registered Live/Pending
Proflex Parks, LLC
2023-05-18
PROFLEX
PROFLEX
97665722 not registered Live/Pending
Spigen Korea Co., Ltd.
2022-11-07
PROFLEX
PROFLEX
97583519 not registered Live/Pending
O'Tech Corporation
2022-09-08
PROFLEX
PROFLEX
97521130 not registered Live/Pending
NRDIK LTD
2022-07-26
PROFLEX
PROFLEX
97374926 not registered Live/Pending
LB Marketing, Inc.
2022-04-21
PROFLEX
PROFLEX
90875222 not registered Live/Pending
Textron Aviation Inc.
2021-08-10
PROFLEX
PROFLEX
90749887 not registered Live/Pending
Cain Food Industries, Inc.
2021-06-02
PROFLEX
PROFLEX
90599960 not registered Live/Pending
Control Solutions, Inc.
2021-03-24
PROFLEX
PROFLEX
90448274 not registered Live/Pending
Hamilton Easter, LLC
2021-01-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.