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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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AURA 10 PET-CT - 05430002734026

Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD

BONE FILE #10 - D9281052100

No Description
W.H. Holden, Inc.
10-5210
In Commercial Distribution

  • D9281052100 ()


  • Bone file/rasp, reciprocating, single-use

Vivapore 10/20 - 05060602430112

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP2003
In Commercial Distribution

  • 05060602430112 ()
  • 05060602430358 ()


  • Laboratory dialyser

Vivapore 10/20 - 05060602430105

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP2002
In Commercial Distribution

  • 05060602430105 ()
  • 05060602430358 ()


  • Laboratory dialyser

Vivapore 10/20 - 05060602430099

The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
SARTORIUS STEDIM LAB LIMITED
VP2001
In Commercial Distribution

  • 05060602430099 ()
  • 05060602430358 ()


  • Laboratory dialyser

NewLife Intensity 10 - M638AS0994U0

Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options, Re-manufactured.
AIRSEP CORPORATION
AS099-4U
In Commercial Distribution

  • M638AS0994U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS09940

Oxygen Concentrator, 1-10 LPM, Dual flow with standard 1-10 LPM flow meters, Oxygen Monitor options.
AIRSEP CORPORATION
AS099-4
In Commercial Distribution

  • M638AS09940 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS0991U0

Oxygen Concentrator, 1-10 LPM, Dual flow option with standard 1-10 LPM flow meters.
AIRSEP CORPORATION
AS099-1U
In Commercial Distribution

  • M638AS0991U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS099101U0

Oxygen Concentrator, 1-10 LPM, Single flow, with Oxygen Monitor, Re-manufactured.
AIRSEP CORPORATION
AS099-101U
In Commercial Distribution

  • M638AS099101U0 ()


  • Stationary oxygen concentrator

NewLife Intensity 10 - M638AS0991010

Oxygen Concentrator, 1-10 LPM Single Flow Meter with Oxygen Monitor option
AIRSEP CORPORATION
AS099-101
In Commercial Distribution

  • M638AS0991010 ()


  • Stationary oxygen concentrator
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