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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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Suture Hook with Left curl
GENESEE BIOMEDICAL, INC.
RSH-L
In Commercial Distribution

  • B040RSHL1 ()
  • B040RSHL0 ()


  • Ligature loop applier
Aortic Repair Tool Kit - Cusp Calipers
GENESEE BIOMEDICAL, INC.
ARC-10
In Commercial Distribution

  • B040ARC10 ()
  • B040ARC100 ()


  • Aortic valve cusp height ruler
Reusable 10x, Sterile 800 Micrometer Surgical Optical Fiber RFID
TYPENEX MEDICAL LLC
MF800RST205
Not in Commercial Distribution

  • B050MF800RST2051 ()
  • B050MF800RST2050 ()

  • Outer Diameter: 800 Micrometer


  • Laser lithotripsy system
Reusable 10x, Sterile 550 Micrometer Surgical Optical Fiber RFID
TYPENEX MEDICAL LLC
MF550RST205
Not in Commercial Distribution

  • B050MF550RST2051 ()
  • B050MF550RST2050 ()

  • Outer Diameter: 550 Micrometer


  • Laser lithotripsy system
Reusable 10x, Sterile 365 Micrometer Surgical Optical Fiber RFID
TYPENEX MEDICAL LLC
MF365RST205
Not in Commercial Distribution

  • B050MF365RST2051 ()
  • B050MF365RST2050 ()

  • Outer Diameter: 365 Micrometer


  • Laser lithotripsy system
Reusable 10x, Sterile 272 Micrometer Surgical Optical Fiber RFID
TYPENEX MEDICAL LLC
MF272RST205
Not in Commercial Distribution

  • B050MF272RST2051 ()
  • B050MF272RST2050 ()

  • Outer Diameter: 272 Micrometer


  • Laser lithotripsy system
Reusable 10x, Sterile 200 Micrometer Surgical Optical Fiber RFID
TYPENEX MEDICAL LLC
MF200RST205
Not in Commercial Distribution

  • B050MF200RST2051 ()
  • B050MF200RST2050 ()

  • Outer Diameter: 200 Micrometer


  • Laser lithotripsy system
Fibernex 940 micrometer Reusable Holmium Laser Fibers
TYPENEX MEDICAL LLC
LF0201X940
Not in Commercial Distribution

  • B050LF0201X9403 ()
  • B050LF0201X9400 ()

  • Outer Diameter: 940 Micrometer


  • Laser lithotripsy system
Fibernex 550 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X550
Not in Commercial Distribution

  • B050LF0201X5503 ()
  • B050LF0201X5500 ()

  • Outer Diameter: 550 Micrometer


  • Laser lithotripsy system
Fibernex 365 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X365
Not in Commercial Distribution

  • B050LF0201X3653 ()
  • B050LF0201X3650 ()

  • Outer Diameter: 365 Micrometer


  • Laser lithotripsy system
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