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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™ - 00816959020651

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

  • 00816959020651 ()
R-LLF365AU, R-LLF365AU-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020644

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

  • 00816959020644 ()
S-LLF365AU, S-LLF365AU-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020637

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

  • 00816959020637 ()
S-LLF273TRC, S-LLF273TRC-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020620

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

  • 00816959020620 ()
S-LLF200TRC, S-LLF200TRC-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™ - 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™ - 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

Dornier Thulio Performance Fiber - 00816959021887

No Description
INNOVAQUARTZ LLC
200um Reusable Fiber
In Commercial Distribution

  • 10816959021884 ()
  • 00816959021887 ()
K2016369

  • General/multiple surgical laser system beam guide, reusable

Dornier Thulio Performance Fiber - 00816959021870

No Description
INNOVAQUARTZ LLC
200um Single-Use Fiber
In Commercial Distribution

  • 10816959021877 ()
  • 00816959021870 ()
K2016360

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021863

No Description
INNOVAQUARTZ LLC
910 Single-Use Laser Lithotripsy Fiber
In Commercial Distribution

  • 00816959021863 ()
S-LLF910-USL, S-LLF1000-USL

  • General/multiple surgical laser system beam guide, reusable
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