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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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TroClear - B606TC90

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC9
In Commercial Distribution

  • B606TC96 ()
  • B606TC90 ()
  • B606TC97 ()
TC9

  • Surgical instrument/endoscope cleaning utensil, single-use

TroClear - B606TC70

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC7
In Commercial Distribution

  • B606TC76 ()
  • B606TC70 ()
  • B606TC77 ()
TC7

  • Surgical instrument/endoscope cleaning utensil, single-use

TroClear - B606TC110

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC11
In Commercial Distribution

  • B606TC116 ()
  • B606TC110 ()
  • B606TC117 ()
TC11

  • Surgical instrument/endoscope cleaning utensil, single-use

Gesiva Medical - B598GMMHT0001

No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

  • B598GMMHT0001 ()
  • B598GMMHT0002 ()
  • B598GMTRK0001 ()


  • Penile vacuum device

TroClear - B606TC80

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC8
In Commercial Distribution

  • B606TC86 ()
  • B606TC80 ()
  • B606TC87 ()
TC8

  • Surgical instrument/endoscope cleaning utensil, single-use

TroClear - B606TC50

Trocar squeegee cleaning system is a single use, multiple use per patient sterile medical device. TroClear TM cleans debris inside the trocar canula during surgery while in-situ. TroClear TM is used in the camera port after a dirty laparoscopic camera is pulled through the trocar. TroClear TM squeegees the canula clean in a single pass, then captures the debris inside a sheath prior to withdraw to ensure a clean canula for camera re-entry. TroClear TM can be rinsed clean and reused multiple times per patient per IFU.
Mednium Corporation
TC5
In Commercial Distribution

  • B606TC56 ()
  • B606TC50 ()
  • B606TC57 ()
TC5

  • Surgical instrument/endoscope cleaning utensil, single-use

TroClear - B606TC10SPD1

Hospital SPD trocar squeegee cleaning system is a non-sterile multiple use per IFU medical device. TroClear SPD TM cleans debris inside the trocar canula, TroClear TM SPD squeegees the canula clean in a single pass. TroClear TM SPD can be rinsed clean and reused multiple times per IFU.
Mednium Corporation
TC10SPD
In Commercial Distribution

  • B606TC10SPD6 ()
  • B606TC10SPD1 ()
  • B606TC10SPD7 ()
TC10SPD

  • Surgical instrument/endoscope cleaning utensil, reusable

Vios Monitoring System Pulse Oximetry Sensor - B595L2050R0

The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions. The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable

SH 77-7 Oropharyngeal Airway - M996SH7770

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 100 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-7
In Commercial Distribution

  • M996SH7775 ()
  • M996SH7770 ()
  • M996SH7772 ()

  • Length: 90 Millimeter


  • Oropharyngeal airway, single-use

SH 77-6 Oropharyngeal Airway - M996SH7760

Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 90 mm.
INSTRUMENTATION INDUSTRIES, INCORPORATED
SH 77-6
In Commercial Distribution

  • M996SH7765 ()
  • M996SH7760 ()
  • M996SH7762 ()

  • Length: 90 Millimeter


  • Oropharyngeal airway, single-use
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