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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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Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8067M0K1
In Commercial Distribution

  • M2138067M0K15 ()

  • Total Volume: 0.8 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Can be used in place of Cardiac Science™ electrodes part # 9131-001. Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)
HEART SYNC INC
T100-CS
In Commercial Distribution

  • 00868866000004 ()
  • 10868866000001 ()
T100-CS

  • Electrode conductive skin pad, single-use
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System. The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
Endotronix, Inc.
100102-01
In Commercial Distribution

  • 00850008997013 ()


  • Implantable pulmonary artery pressure monitoring system
USED LP1000 CONFIG UNIT1000AAAABAAACBBAAAAAAAAA
PHYSIO-CONTROL, INC.
99425
In Commercial Distribution

  • 00883873778876 ()
99425-000025U

  • Non-rechargeable professional semi-automated external defibrillator
ASSY-LP CR PLUS,SEMI,CHECK FOR PULSE
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000001

  • Rechargeable public semi-automated external defibrillator
ASSY-LPCR PLUS,AUTO,ENGLISH,AHA2005, FDA
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000157

  • Rechargeable public automated external defibrillator
ASSY-LPCR PLUS,SEMI,ENGLISH,AHA2005, FDA
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000156

  • Rechargeable public semi-automated external defibrillator
DEVICE,LPCR,AUTO, BREATH,EN
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000170

  • Rechargeable public automated external defibrillator
DEVICE,LPCR,SEMI,BREATH,EN
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000169

  • Rechargeable public semi-automated external defibrillator
DEVICE,LPCR,AUTO,CIRC, EN
PHYSIO-CONTROL, INC.
99403
In Commercial Distribution

99403-000167

  • Rechargeable public automated external defibrillator
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