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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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Elation 5™ - 00884450487082

No Description
Merit Medical Systems, Inc.
00884450487082
In Commercial Distribution

  • 10884450487089 ()
  • 00884450487082 ()

  • Balloon Outer Diameters-9 mm, 10 mm, 11 mm, 12 mm, 13 mm
EPX10

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487075

No Description
Merit Medical Systems, Inc.
00884450487075
In Commercial Distribution

  • 10884450487072 ()
  • 00884450487075 ()

  • Balloon Outer Diameters-7 mm, 8 mm, 9 mm, 10 mm, 11 mm
EPX8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487068

No Description
Merit Medical Systems, Inc.
00884450487068
In Commercial Distribution

  • 10884450487065 ()
  • 00884450487068 ()

  • Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm
EPX6

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

FleXNeedle (5 pack) - 00856571007210

Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
BRONCUS MEDICAL INC.
10005-2
In Commercial Distribution

  • 00856571007210 ()

  • Needle Gauge: 18 Gauge
10005-2

  • Soft-tissue biopsy needle, single-use

SleepmateThermistor - Alice 5 - 05707480042180

Alice 5 Thermistor
Ambu A/S
814910-121
In Commercial Distribution

  • 05707480042180 ()
814910-121

  • Polysomnograph

SleepmateCannuTherm, - Alice 5 - 05707480042043

Ref. 1464
Ambu A/S
814310-121
Not in Commercial Distribution

  • 05707480042043 ()
814310-121

  • Polysomnograph

AirSep FreeStyle 5 - M766AS077101CU0

AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured
CAIRE INC.
AS077-101CU
In Commercial Distribution

  • M766AS077101CU0 ()


  • Mobile/portable oxygen concentrator

EVA 5 Insufflator - 05391536920296

Endoscopic Insufflator
PALLIARE LIMITED
EVA5
In Commercial Distribution

  • 05391536920296 ()


  • Gastrointestinal endoscopic insufflator

Fusion Bond 5 - D96710004

No Description
PREVEST DENPRO LIMITED
Economy Pack
In Commercial Distribution

  • D96710004 ()
10004

  • Dental acrylic resin kit

Fusion Bond 5 - D96710003

No Description
PREVEST DENPRO LIMITED
Intro Pack
In Commercial Distribution

  • D96710003 ()
10003

  • Dental acrylic resin kit
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