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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™ - 00816959020132

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

  • 00816959020132 ()
S-LLF365SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020125

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

  • 00816959020125 ()
S-LLF273SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020118

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

  • 00816959020118 ()
S-LLF200SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020101

Maximum Power (J x PPS): 10W Wavelengths Range: 500nm to 2200nm
INNOVAQUARTZ LLC
Single Use 150 Laser Lithotripsy Fiber var. SPY
In Commercial Distribution

  • 00816959020101 ()
SLLF150SPY

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020811

No Description
INNOVAQUARTZ LLC
DSU200PT
In Commercial Distribution

  • 00816959020811 ()
DSU200PT

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020804

No Description
INNOVAQUARTZ LLC
LSU273PT
In Commercial Distribution

  • 00816959020804 ()
LSU273PT

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020798

No Description
INNOVAQUARTZ LLC
LSU200PT
In Commercial Distribution

  • 00816959020798 ()
LSU200PT

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020781

No Description
INNOVAQUARTZ LLC
TSU1000PF
In Commercial Distribution

  • 00816959020781 ()
TSU1000PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020767

No Description
INNOVAQUARTZ LLC
TSU365PF
In Commercial Distribution

  • 00816959020767 ()
TSU365PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020743

No Description
INNOVAQUARTZ LLC
TSU200PF
In Commercial Distribution

  • 00816959020743 ()
TSU200PF

  • General/multiple surgical laser system beam guide, reusable
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