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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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Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
pfm medical ag
145096V2
In Commercial Distribution

  • 4042301160027 ()
  • 04042301160010 ()

  • 9 x 6
145096V2

  • Cardiac defect occluder
Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
pfm medical ag
145054V2
In Commercial Distribution

  • 4042301159960 ()
  • 04042301159953 ()

  • 5 x 4


  • Cardiac defect occluder
The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-300
Not in Commercial Distribution

  • 00857334004316 ()

  • Outer Diameter: 5 Inch
2403-300

  • Vagus nerve electrical stimulation system programmer
single use kit for cleaning the product after a neuro clinical treatment
INSIGHTEC LTD
neuro cleaning kit for USA
In Commercial Distribution

  • 07290015461160 ()
SET000933

  • Therapeutic oncological/gynaecological ultrasound system
Blood glucose test strips. Sold in a carton of 15 test strips.
ASCENSIA DIABETES CARE US INC.
7550
In Commercial Distribution

  • 40301937550155 ()
  • 00301937550157 ()
  • 10301937550154 ()
  • 00301937550065 ()
90001174

  • Glucose monitoring system IVD, home-use
Tubal Occluding Device in a sterile pouch (2 Hulka Clips per pouch)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
4986.90
Not in Commercial Distribution

  • 00861523000102 ()
  • 10861523000109 ()
4986.09

  • Fallopian tube clip/band
A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).
CARDIOCOMMAND, INC.
2A re-man'd, unpackaged
In Commercial Distribution

  • 00856233005158 ()
8002A-9999

  • External pacemaker, transoesophageal pacing
A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit).
CARDIOCOMMAND, INC.
2A, unpackaged
In Commercial Distribution

  • 00856233005066 ()
8002A

  • External pacemaker, transoesophageal pacing
A portable case that holds the Monitor while wearing the ASSURE system
Kestra Medical Technologies, Inc.
3326502-003
In Commercial Distribution

  • 00840241600207 ()
3326502-003

  • Wearable defibrillation system defibrillator
Eversense E3 Pouch contains one Eversense E3 Sensor in a Sensor holder.
SENSEONICS, INCORPORATED
102095-81A
In Commercial Distribution

  • 00817491023063 ()


  • Implantable glucose monitoring system sensor
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