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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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Azur Detachable Helical HydroCoil - 00810170014390

Azur
MICROVENTION INC.
45-450505
In Commercial Distribution

  • 00810170014390 ()

  • 5 mm x 5 cm
45-450505

  • Non-neurovascular embolization coil

Azur Detachable Helical HydroCoil - 00812636020518

Azur
MICROVENTION INC.
45-480505
In Commercial Distribution

  • 00812636020518 ()

  • 5 mm x 5 cm
45-480505

  • Non-neurovascular embolization coil

Azur Detachable Helical HydroCoil - 00812636020471

Azur
MICROVENTION INC.
45-480505
In Commercial Distribution

  • 00812636020471 ()

  • 5 mm x 5 cm
45-480505

  • Non-neurovascular embolization coil

Ambu WhiteSensor WS - 05707480141807

Ambu WhiteSensor WS/RT
Ambu A/S
WS-00-S/RT/5
Not in Commercial Distribution

  • 05707480141821 ()
  • 05707480141814 ()
  • 05707480141807 ()
  • 05707480141791 ()
WS-00-S/RT/5

  • Electrocardiographic electrode, single-use

SJM™ - 05414734503365

STYLET KIT (for SJM™ LV OTW Leads)
ST. JUDE MEDICAL, INC.
4078S/86/5
In Commercial Distribution

  • 05414734503365 ()

  • Length: 86 Centimeter
  • Length: 5 Centimeter
4078S/86/5

  • Pacing/defibrillation lead stylet

SJM™ - 05414734500654

STYLET KIT (for SJM™ LV OTW Leads)
ST. JUDE MEDICAL, INC.
4078S/75/5
In Commercial Distribution

  • 05414734500654 ()

  • Length: 75 Centimeter
  • Length: 5 Centimeter
4078S/75/5

  • Pacing/defibrillation lead stylet

ON-Q* Pain Relief System with ONDEMAND* Bolus Button - 00193494136871

ON-Q* Pain Relief System with ONDEMAND* Bolus Button, 400 ml, 5 ml/hr, 5 ml bolus/60 min
Avanos Medical, Inc.
13687
In Commercial Distribution

  • 10193494136878 ()
  • 00193494136871 ()

  • Total Volume: 400 Milliliter
  • Balloon Fill Volume (ml)
P400X5+5/60

  • Elastomeric infusion pump system

ON-Q* Pain Relief System, ON-Q* Pump with SELECT-A-FLOW* - 00193494136864

ON-Q* Pain Relief System, ON-Q* Pump with SELECT-A-FLOW* Variable Rate Controller and ONDEMAND* Bolus Button
Avanos Medical, Inc.
13686
In Commercial Distribution

  • 10193494136861 ()
  • 00193494136864 ()

  • Total Volume: 400 Milliliter
  • Balloon Fill Volume (ml)
P400X2-14+5/30

  • Elastomeric infusion pump system

ON-Q* Pain Relief System with SELECT-A-FLOW* - 00193494136840

ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller and ONDEMAND* Bolus Button, 400 ml x Basal 1-7 ml/hr, Bolus 5ml/60 min
Avanos Medical, Inc.
13684
In Commercial Distribution

  • 10193494136847 ()
  • 00193494136840 ()

  • Total Volume: 400 Milliliter
  • Balloon Fill Volume (ml)
P400X1-7+5/60

  • Elastomeric infusion pump system

OWL - 00825114007826

OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 150mm LONG, 5mm BARE TIP
Diros Technology Inc
DHC-022/150/5
In Commercial Distribution

  • 00825114007833 ()
  • 00825114007826 ()
DHC-022/150/5

  • Percutaneous radio-frequency ablation probe cannula, single-use
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