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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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Bone Screw
MAKO SURGICAL CORP.
186005-15
In Commercial Distribution

  • 00848486008451 ()

  • Diameter: 6.5 Millimeter
  • Length: 15.0 Millimeter
186005-15

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
OXOID LIMITED
CT0249B
In Commercial Distribution

  • 05032384006564 ()
  • 05032384502363 ()


  • Cefoperazone susceptibility testing disc IVD
Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI.
Zoll Medical Corporation
8700-010001-01
In Commercial Distribution

  • 00847946021870 ()


  • Electrocardiography telemetric monitoring system
Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI.
Zoll Medical Corporation
8000-000619
In Commercial Distribution

  • 00847946021863 ()


  • Electrocardiography telemetric monitoring system
X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, CPR EXPANSION PACK, ETCO2, DMST
Zoll Medical Corporation
610-0121411-01
In Commercial Distribution

  • 00847946045470 ()


  • Noninvasive device battery charger
  • Internal defibrillation electrode, paediatric
  • Multifunction cardiac electrode, paediatric
  • Blood pressure cuff, single-use
  • External defibrillation electrode, paediatric, reusable
  • Internal defibrillation electrode, adult, reusable
  • Nasal oxygen cannula, carbon-dioxide-sampling
  • External defibrillation electrode, adult, single-use
  • Electrocardiographic electrode, single-use
  • Rechargeable professional automated external defibrillator
No Description
OXOID LIMITED
CT0417B
In Commercial Distribution

  • 05032384006656 ()
  • 05032384502332 ()


  • Ceftriaxone susceptibility testing disc IVD
Post-Operative Care Kit with 12/55 Tube & EasyFlow HME
Freudenberg Medical, LLC
PK 2107
In Commercial Distribution

  • 00848253003641 ()


  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
Post-Operative Care Kit with 12/55 Tube & ClassicFlow HME
Freudenberg Medical, LLC
PK 2106
In Commercial Distribution

  • 00848253003634 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Voice Prosthesis
Freudenberg Medical, LLC
PK 2105
In Commercial Distribution

  • 00848253003443 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
  • Tracheoesophageal speech valve occluder, non-valved
  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling
Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx
Freudenberg Medical, LLC
PK 2104
In Commercial Distribution

  • 00848253003436 ()


  • Transcervical artificial larynx
  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
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