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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EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm
Endosound, Inc.
5010
In Commercial Distribution

  • 00850050934097 ()
  • 00850050934059 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5009

  • General-purpose ultrasound imaging system
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
Endosound, Inc.
5006
In Commercial Distribution

  • 00850050934080 ()
  • 00850050934073 ()

  • Lumen/Inner Diameter: 9 Millimeter
  • 1mm wall thickness
5005

  • General-purpose ultrasound imaging system
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 10.5mm Wall Thickness: 0.5mm
Endosound, Inc.
5004
In Commercial Distribution

  • 00850050934042 ()
  • 00850050934004 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • .5mm wall thickness
5003

  • General-purpose ultrasound imaging system
DCS 010 Drainage Collection System
Irras USA, Inc.
DCS 010
In Commercial Distribution

  • 10868643000477 ()
  • 00868643000470 ()
DCS 010

  • Intracerebral sensor catheter, short-term
  • Intracranial pressure monitor
Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
NERBIO PRIVATE LIMITED
ITOFDEV01
In Commercial Distribution

  • 00860012119660 ()
  • 00860012119677 ()


  • Block-monitoring peripheral nerve electrical stimulation system
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 3-Sphere
Cardio Flow, Inc.
H6004
In Commercial Distribution

  • 00850040691085 ()
  • 00850040691108 ()

  • Atherectomy Rotating Component Diameter: 1.5 Millimeter


  • Mechanical atherectomy system catheter, peripheral
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere
Cardio Flow, Inc.
H6002
In Commercial Distribution

  • 00850040691054 ()
  • 90850040691064 ()

  • Atherectomy Rotating Component Diameter: 2.0 Millimeter


  • Mechanical atherectomy system catheter, peripheral
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 5-sphere
Cardio Flow, Inc.
H6001
In Commercial Distribution

  • 00850040691030 ()
  • 90850040691040 ()

  • Atherectomy Rotating Component Diameter: 1.5 Millimeter


  • Mechanical atherectomy system catheter, peripheral
Cardio Flow Peripheral Guide Wire Guidewire, 325 CM
Cardio Flow, Inc.
GW1001
In Commercial Distribution

  • 00850040691023 ()
  • 00850040691009 ()
  • 00850040691016 ()

  • Guidewire Length: 325 Centimeter


  • Peripheral vascular guidewire, manual
No Description
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
EL-580FN
Not in Commercial Distribution

  • 00856853006016 ()


  • Rigid video laparoscope
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