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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™ - 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™ - 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

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™ - 00816959020484

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020484 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020361

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020361 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020347

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

  • 00816959020347 ()
S-LLF910-T, S-LLF1000-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020323

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

  • 00816959020323 ()
S-LLF550-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020309

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020309 ()
S-LLF365-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020279

Maximum Power (J x PPS): 30W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Reusable 200 Laser Lithotripsy Fiber var. Trimedyne
In Commercial Distribution

  • 00816959020279 ()
R-LLF200TG-T

  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020255

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020255 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020248

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020248 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020231

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020231 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020224

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020224 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020217

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020217 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020200

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020200 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020194

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020194 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020187

No Description
INNOVAQUARTZ LLC
Laser Lithotripsy Fiber
Not in Commercial Distribution

  • 00816959020187 ()


  • General/multiple surgical laser system beam guide, reusable

ProFlex™ - 00816959020170

Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
INNOVAQUARTZ LLC
Single Use 365 Laser Lithotripsy Fiber var. SPY Trimedyne
In Commercial Distribution

  • 00816959020170 ()
S-LLF365SPY-T

  • General/multiple surgical laser system beam guide, reusable

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
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