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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ProFlex™ - 00816959020613

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 910 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020613 ()
R-LLF910, R-LLF910-OCS, R-LLF1000, R-LLF1000-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020606

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 910 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020606 ()
S-LLF910, S-LLF910-OCS, S-LLF1000, S-LLF1000-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020590

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 550 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020590 ()
R-LLF550, R-LLF550-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020583

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 550 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020583 ()
S-LLF550, S-LLF550-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020576

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 365 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020576 ()
R-LLF365, R-LLF365-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020569

Maximum Power (J x PPS): 120W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020569 ()
S-LLF365, S-LLF365-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020552

Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 273 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020552 ()
R-LLF273LT, R-LLF273TG, R-LLF273-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020545

Maximum Power (J x PPS): 50W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020545 ()
S-LLF273LT, S-LLF273TG, S-LLF273-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020538

Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Reusable 200 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020538 ()
R-LLF200LT, R-LLF200TG, R-LLF200-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020521

Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
INNOVAQUARTZ LLC
Single Use 200 Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959020521 ()
S-LLF200LT, S-LLF200TG, S-LLF200-OCS

  • General/multiple surgical laser system beam guide, reusable
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