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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™ - 00816959020163

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020163 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020156

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020156 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020149

Maximum Power (J x PPS): 50W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 273 Laser Lithotripsy Fiber var. SPY Trimedyne
In Commercial Distribution

  • 00816959020149 ()
S-LLF273SPY-T

  • General/multiple surgical laser system beam guide, reusable

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

ProFlex - 00816959020736

No Description
INNOVAQUARTZ LLC
SU1000PF
In Commercial Distribution

  • 00816959020736 ()
SU1000PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020729

No Description
INNOVAQUARTZ LLC
SU550PF
In Commercial Distribution

  • 00816959020729 ()
SU550PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020712

No Description
INNOVAQUARTZ LLC
SU365PF
In Commercial Distribution

  • 00816959020712 ()
SU365PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020705

No Description
INNOVAQUARTZ LLC
LSU273PF
In Commercial Distribution

  • 00816959020705 ()
LSU273PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020699

No Description
INNOVAQUARTZ LLC
DSU273PF
In Commercial Distribution

  • 00816959020699 ()
DSU273PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020682

No Description
INNOVAQUARTZ LLC
LSU200PF
In Commercial Distribution

  • 00816959020682 ()
LSU200PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020675

ProFlex® 200 Laser Lithotripsy Fiber Single-Use
INNOVAQUARTZ LLC
DSU200PF
In Commercial Distribution

  • 00816959020675 ()
DSU200PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020668

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

  • 00816959020668 ()
R-LLF550AU, R-LLF550AU-OCS

  • General/multiple surgical laser system beam guide, reusable

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

ProFlex™ - 00816959021856

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

  • 00816959021856 ()
S-LLF910-T-USL, S-LLF1000-T-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021849

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

  • 00816959021849 ()
S-LLF550-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021832

No Description
INNOVAQUARTZ LLC
550 Single-Use Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959021832 ()
S-LLF550-T-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021825

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

  • 00816959021825 ()
S-LLF365-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021818

No Description
INNOVAQUARTZ LLC
365 Single-Use Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959021818 ()
S-LLF365-T-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021801

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

  • 00816959021801 ()
S-LLF273TG-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021795

No Description
INNOVAQUARTZ LLC
273 Single-Use Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959021795 ()
S-LLF273TG-T-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021788

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

  • 00816959021788 ()
S-LLF273LT-USL

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959021771

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

  • 00816959021771 ()
S-LLF200TG-USL

  • General/multiple surgical laser system beam guide, reusable
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