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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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Alpha-Stim Earclip Electrode (AID) - 00857869005178

Alpha-Stim Earclip Electrode (AID) RoHS compliant
Electromedical Products International, Inc.
Earclip Electrode (AID) [RoHS]
Not in Commercial Distribution

  • 00857869005178 ()


  • Transcutaneous electrical stimulation electrode, single-use

Alpha-Stim Earclip Electrode (M) - 00857869005161

Alpha-Stim Earclip Electrode (M) RoHS compliant
Electromedical Products International, Inc.
Earclip Electrode (M) [RoHS]
Not in Commercial Distribution

  • 00857869005161 ()


  • Transcutaneous electrical stimulation electrode, single-use

Alpha-Stim Earclip Electrode (AID) - 00857869005130

Alpha-Stim Earclip Electrode (AID)
Electromedical Products International, Inc.
Earclip Electrode (AID)
In Commercial Distribution

  • 00857869005130 ()


  • Transcutaneous electrical stimulation electrode, single-use

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000035

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with "Anderson" adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100
Not in Commercial Distribution

  • 10868866000032 ()
  • 00868866000035 ()
Sterile-C100

  • Electrode conductive skin pad, single-use

AMDS Hybrid Prosthesis ("AMDS") - 00877234001338

40mm (Classic) Straight Stent (28mm collar)
Artivion, Inc.
K038895
In Commercial Distribution

  • 00877234001338 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length: 207mm
  • Stent Collar Diameter: 28mm
AMDS40c

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001321

40mm – 30mm (Classic) Tapered Stent (28mm collar)
Artivion, Inc.
K038896
In Commercial Distribution

  • 00877234001321 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 20-24mm
  • Aortic Stent Minimum Length:159mm
  • Aortic Stent Maximum Length: 203mm
  • Stent Collar Diameter: 28mm
AMDS4030c

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001222

55mm – 40mm Tapered Stent (32mm collar)
Artivion, Inc.
K039423
In Commercial Distribution

  • 00877234001222 ()

  • Catheter Length: 546 Millimeter
  • Aortic Stent Proximal Diameter: 36-45mm
  • Aortic Stent Distal Diameter: 27-35mm
  • Aortic Stent Minimum Length:185mm
  • Aortic Stent Maximum Length:211mm
  • Stent Collar Diameter: 32mm
AMDS5540

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001208

40mm – 30mm Tapered Stent (24mm collar)
Artivion, Inc.
K039421
In Commercial Distribution

  • 00877234001208 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 20-24mm
  • Aortic Stent Minimum Length:159mm
  • Aortic Stent Maximum Length:203mm
  • Stent Collar Diameter: 24mm
AMDS4030

  • Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") - 00877234001192

40mm Straight Stent (24mm collar)
Artivion, Inc.
K039420
In Commercial Distribution

  • 00877234001192 ()

  • Catheter Length: 527 Millimeter
  • Aortic Stent Proximal Diameter: 20-35mm
  • Aortic Stent Distal Diameter: 25-35mm
  • Aortic Stent Minimum Length:153mm
  • Aortic Stent Maximum Length:207mm
  • Stent Collar Diameter: 24mm
AMDS40

  • Bare-metal aortic stent

Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes - 00868866000028

The Heart Sync Sterile Adult Radio Transparent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Zoll adapted models of monophasic and bi-phasic defibrillators.
HEART SYNC INC
Sterile-C100-Zoll
Not in Commercial Distribution

  • 10868866000025 ()
  • 00868866000028 ()
Sterile-C100-Zoll

  • Electrode conductive skin pad, single-use
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