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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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Fibernex - B050LF0201X9400

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 - B050LF0201X5500

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 - B050LF0201X3650

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

  • B050LF0201X3653 ()
  • B050LF0201X3650 ()

  • Outer Diameter: 365 Micrometer


  • Laser lithotripsy system

Fibernex - B050LF0201X2720

Fibernex 272 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X272
Not in Commercial Distribution

  • B050LF0201X2723 ()
  • B050LF0201X2720 ()

  • Outer Diameter: 272 Micrometer


  • Laser lithotripsy system

Fibernex - B050LF0201X2000

Fibernex 200 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X200
Not in Commercial Distribution

  • B050LF0201X2003 ()
  • B050LF0201X2000 ()

  • Outer Diameter: 200 Micrometer


  • Laser lithotripsy system

Adult Curved Sternal Latch Retractor with Atrial and Aortic Rakes - B040SRLPAR0

Large Patient Curved Sternal Latch Retractor with 2 sets of Blades, and Atrial and Aortic Rakes: Suitable for adult patients >90 kg or with BMI of 35 or above
GENESEE BIOMEDICAL, INC.
SRLP-AR
In Commercial Distribution

  • B040SRLPAR1 ()
  • B040SRLPAR0 ()
SRLP-AR

  • Sternum spreader

Adult Curved Sternal Latch Retractor - B040SRLP10

Large Patient Curved Sternal Latch Retractor with 2 sets of Blades Suitable for adult patients >90 kg or with BMI of 35 or above
GENESEE BIOMEDICAL, INC.
SRLP-1
In Commercial Distribution

  • B040SRLP1 ()
  • B040SRLP10 ()
SRLP-1

  • Sternum spreader

Robotic Tool Kit Valve Sizer Stainless - B040RTKVSS0

Stainless Steel Valve Sizers Reusable
GENESEE BIOMEDICAL, INC.
RTK-VSS
In Commercial Distribution

  • B040RTKVSS1 ()
  • B040RTKVSS0 ()


  • Heart valve annulus sizer, reusable

Robotic Tool Kit Knot Pusher Closed - B040RTKRKP0

Suture Knot Pusher with Closed Tip
GENESEE BIOMEDICAL, INC.
RTK-RKP
In Commercial Distribution

  • B040RTKRKP1 ()
  • B040RTKRKP0 ()


  • Suture knot pusher, reusable

Robotic Tool Kit Large Diameter Suction - B040RTKLDS0

Suction Tool with Large single lumen
GENESEE BIOMEDICAL, INC.
RTK-LDS
In Commercial Distribution

  • B040RTKLDS1 ()
  • B040RTKLDS0 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
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