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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™ - 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

Bio Protech - 00817120020753

9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch, 40 pouches in Master Case)
BIO PROTECH USA, INC.
9552F
In Commercial Distribution

  • 10817120020750 ()
  • 00817120020753 ()


  • Electrosurgical return electrode, single-use

Bio Protech - 00817120020746

P9552F - Grounding Pads, Corded, Adult, Foam, Dual Pad, Horizontal (1pc per pouch, 25pc per box, 8box per case)
BIO PROTECH USA, INC.
P9552F
In Commercial Distribution

  • 10817120020743 ()
  • 00817120020746 ()
  • 10817120020002 ()


  • Electrosurgical return electrode, single-use

Bio Protech - 00817120020739

9551F- Grounding Pads, Dispersive Electrode, Adult, Foam, Non-Corded, Single Pad, Horizontal (5 pcs/pouch, 40 pouches in Master Case)
BIO PROTECH USA, INC.
9551F
In Commercial Distribution

  • 10817120020736 ()
  • 00817120020739 ()


  • Electrosurgical return electrode, single-use

Bio Protech - 00817120020722

P9551F- Grounding Pad, Corded, Foam, Adult, Single, Horizontal (1 pc/ pouch, 100 pouches in a Master Case).
BIO PROTECH USA, INC.
P9551F
In Commercial Distribution

  • 10817120020729 ()
  • 00817120020722 ()


  • Electrosurgical return electrode, single-use

Bio Protech - 00817120020487

P9552F - Grounding Pads, Corded, Adult, Foam, Dual Pad, Horizontal (Do Not Use)
BIO PROTECH USA, INC.
P9552F
In Commercial Distribution

  • 20817120020481 ()
  • 10817120020484 ()
  • 00817120020487 ()


  • Electrosurgical return electrode, single-use

Bio Protech - 00817120020470

P9551F- Grounding Pad, Corded, Foam, Adult, Single, Horizontal (DO NOT USE)
BIO PROTECH USA, INC.
P9551F
In Commercial Distribution

  • 00817120020470 ()
  • 10817120020477 ()
  • 20817120020474 ()


  • Electrosurgical return electrode, single-use

Bio Protech - 00817120020296

9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch, 40 pouches in Master Case) (Do Not Use)
BIO PROTECH USA, INC.
9552F
In Commercial Distribution

  • 20817120020290 ()
  • 10817120020293 ()
  • 00817120020296 ()


  • Electrosurgical return electrode, single-use
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