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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 - 00816959020781

No Description
INNOVAQUARTZ LLC
TSU1000PF
In Commercial Distribution

  • 00816959020781 ()
TSU1000PF

  • General/multiple surgical laser system beam guide, reusable

ProFlex - 00816959020774

No Description
INNOVAQUARTZ LLC
TSU550PF
In Commercial Distribution

  • 00816959020774 ()
TSU550PF

  • 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 - 00816959020736

No Description
INNOVAQUARTZ LLC
SU1000PF
In Commercial Distribution

  • 00816959020736 ()
SU1000PF

  • 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 - 00816959020699

No Description
INNOVAQUARTZ LLC
DSU273PF
In Commercial Distribution

  • 00816959020699 ()
DSU273PF

  • 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™ - 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™ - 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™ - 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™ - 00816959020507

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

  • 00816959020507 ()
S-LLF150LT

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020491

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

  • 00816959020491 ()
S-LLF550AU, S-LLF550AU-OCS

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020477

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020477 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020453

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020453 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020439

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020439 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020392

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020392 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020378

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020378 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020354

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 910 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020354 ()
R-LLF910-T, R-LLF1000-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020330

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 550 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020330 ()
R-LLF550-T

  • General/multiple surgical laser system beam guide, reusable
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