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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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Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1 in. x 1.25 in. and are single patient use only.
AMPCARE, LLC
50709ST
In Commercial Distribution

  • 10867786000214 ()
  • 00867786000217 ()
50709ST

  • Transcutaneous electrical stimulation electrode, single-use
Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patient's skin. An example electrical stimulation current application of these electrodes is neuro-muscular electrical stimulation including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. Each package contains 4 electrodes with a size of 1.5 in. x 1.75 in. and are single patient use only.
AMPCARE, LLC
50709LT
In Commercial Distribution

  • 00867786000200 ()
  • 10867786000207 ()
50709LT

  • Transcutaneous electrical stimulation electrode, single-use
Oxygen Sensor
MAXTEC, LLC
R125P03-002
In Commercial Distribution

  • 00853061006906 ()


  • Respiratory oxygen sensor
4.0MM 50° ABLATOR
E Surgical, LLC
RB4050-01
In Commercial Distribution

  • 00850053927041 ()
RB4050-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 50° ASPIRATING ABLATOR
E Surgical, LLC
RB4050A-01
In Commercial Distribution

  • 10850053927031 ()
  • 00850053927034 ()
RB4050A-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 90° ABLATOR
E Surgical, LLC
RB4090-01
In Commercial Distribution

  • 10850053927024 ()
  • 00850053927027 ()
RB4090-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 90° ASPIRATING ABLATOR
E Surgical, LLC
RB4090A-01
In Commercial Distribution

  • 00850053927010 ()
  • 10850053927017 ()
RB4090A-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
e∙Sense® catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder & Urethral Dual Sensor Catheter; Coudé tip shape.
In Commercial Distribution

  • 08718122046302 ()
  • 38718122046303 ()

  • Coudé tip shape
  • 7F Diameter
  • Length: 40 Centimeter
37042105

  • Urodynamic catheter
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder Single Sensor Catheter; Coudé tip shape
In Commercial Distribution

  • 08718122046296 ()
  • 38718122046297 ()

  • Length: 40 Centimeter
  • 7F Diameter
  • Coudé distal tip shape
37041105

  • Urodynamic catheter
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.
PendraCare International B.V.
Bladder & Urethral Dual Sensor Catheter, straight tip shape
In Commercial Distribution

  • 08718122028339 ()
  • 38718122028330 ()

  • Length: 40 Centimeter
  • 7F Diameter
37042005

  • Urodynamic catheter
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