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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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
Cutter Driver for Plaque Excision Systems
Covidien LP
FG02550
In Commercial Distribution

  • 00821684043318 ()


  • Mechanical atherectomy system catheter, peripheral
Perseus Device Sensor
ORTHOKEY ITALIA SRL
20100801
In Commercial Distribution

  • 08052675960013 ()
20100801

  • Orthopaedic stereotactic surgery system
Biopsy Grid
Philips Ds North America LLC
98960321420
In Commercial Distribution

  • 00884838083608 ()


  • MRI system coil, radio-frequency
Gastroscope
Ambu A/S
582101000
In Commercial Distribution

  • 05707480161867 ()
  • 05707480161850 ()

  • Outer Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
  • Length: 103 Centimeter
582101000

  • Flexible video gastroscope, single-use
NeoNavia FlexiPulse probe
NeoDynamics AB (publ)
2104
Not in Commercial Distribution

  • 27350081940076 ()
  • 17350081940079 ()
  • 37350081940073 ()

  • Needle Gauge: 14 Gauge
2104

  • End-cut biopsy gun needle
The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm
CREO MEDICAL LIMITED
AB1 Instrument
In Commercial Distribution

  • 05060359560193 ()
  • 05060359560209 ()

  • Length: 1.00 Meter
  • Outer Diameter: 2.00 Millimeter
7-AB1-001

  • Microwave ablation system probe, non-powered
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