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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™ - 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

NeuLight® - 00816901023976

No Description
Weinert Fiber Optics, Inc.
WF IR600/630ST-3/SM-F 1030X3S
In Commercial Distribution

  • 01816901023975 ()
  • 00816901023976 ()
  • 02816901023974 ()
098337

  • General/multiple surgical laser system beam guide, reusable

Arthrex® - 00888867062597

DISP SPLIT ADULT RETURN ELECTROD W/C
ARTHREX, INC.
AR-9610SGP
In Commercial Distribution

  • 00888867062597 ()
  • M150AR9610SGP1 ()
  • 10888867062594 ()
AR-9610SGP

  • Electrosurgical return electrode, single-use

NikoSurg - 10853512006643

Neutral Electrodes
NIKOMED USA
4800
In Commercial Distribution

  • 20853512006640 ()
  • 10853512006643 ()
4800

  • Electrosurgical return electrode, single-use

NikoSurg - 10853512006636

Neutral Electrodes
NIKOMED USA
4700
In Commercial Distribution

  • 10853512006636 ()
  • 20853512006633 ()
4700

  • Electrosurgical return electrode, single-use

NikoSurg - 10853512006599

Neutral Electrodes
NIKOMED USA
2508
In Commercial Distribution

  • 10853512006599 ()
  • 30853512006593 ()
  • 20853512006596 ()
2508

  • Electrosurgical return electrode, single-use
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