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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No Description
MAICO Diagnostics GmbH
CCF-200 Fit Tester
In Commercial Distribution

  • 04260176127741 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
CCA-200 Mini Audiometer
In Commercial Distribution

  • 04260176127673 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
CCA-200 Mini Audiometer
In Commercial Distribution

  • 04260176127659 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 42
In Commercial Distribution

  • 04260176127444 ()


  • Tone audiometer
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000088 ()
-

  • MRI phantom, test object
Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000071 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000064 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000033 ()
-

  • MRI phantom, test object
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0 (15 vials (0 to 3.2 mM))
In Commercial Distribution



  • MRI phantom, test object
No Description
MAICO Diagnostics GmbH
MA 42
Not in Commercial Distribution

  • 04260176120902 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 27
In Commercial Distribution

  • 04260176120865 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 1
In Commercial Distribution

  • 04260176120858 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 41
Not in Commercial Distribution

  • 04260176120704 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 25
In Commercial Distribution

  • 04260176120377 ()


  • Tone audiometer
No Description
CORSCIENCE GmbH & Co. KG
CS20401
In Commercial Distribution

  • 04251341900054 ()


  • Bioelectrical signal analysis software
Mammotome Revolve Control Module- Python
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911103165 ()
CA00006003

  • Mammographic stereotactic biopsy system
Control Module Revolve EX - ROW
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911102830 ()
CA000606001

  • Mammographic stereotactic biopsy system
Holster (tetherless vacuum-assisted biopsy system) - Refresh - CE
DEVICOR MEDICAL PRODUCTS, INC.
MEH1
In Commercial Distribution

  • 00841911102823 ()
CA000687001

  • Mammographic stereotactic biopsy system
Control Module Revolve EX - CE
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911102328 ()
CA000507001

  • Mammographic stereotactic biopsy system
Control Module
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911102267 ()


  • Mammographic stereotactic biopsy system
Ultrasound Holster
DEVICOR MEDICAL PRODUCTS, INC.
MHUSH1
In Commercial Distribution

  • 00841911102045 ()


  • Mammographic stereotactic biopsy system
Stereotactic Holster
DEVICOR MEDICAL PRODUCTS, INC.
MSTH1
In Commercial Distribution

  • 00841911101895 ()


  • Mammographic stereotactic biopsy system
Control Module MR Interlock System- DIRECT MARK
DEVICOR MEDICAL PRODUCTS, INC.
MRLB1
In Commercial Distribution

  • 00841911101888 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Remote Keypad
DEVICOR MEDICAL PRODUCTS, INC.
MHKEYP1
In Commercial Distribution

  • 00841911101871 ()


  • Mammographic stereotactic biopsy system
Footswitch
DEVICOR MEDICAL PRODUCTS, INC.
MFOOT1
In Commercial Distribution

  • 00841911101864 ()


  • Mammographic stereotactic biopsy system
Holster and Cable
DEVICOR MEDICAL PRODUCTS, INC.
STCH1
In Commercial Distribution

  • 00841911101840 ()


  • Mammographic stereotactic biopsy system
Software Package
DEVICOR MEDICAL PRODUCTS, INC.
SCMSW6
In Commercial Distribution

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system
Cart Upgrade- DIRECT MARK GTIN
DEVICOR MEDICAL PRODUCTS, INC.
SCMC3
In Commercial Distribution

  • 00841911101826 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Cart
DEVICOR MEDICAL PRODUCTS, INC.
SCMC1
In Commercial Distribution

  • 00841911101819 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Control Module with SmartVac- DIRECT MARK GTIN
DEVICOR MEDICAL PRODUCTS, INC.
SCM23
In Commercial Distribution

  • 00841911101802 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Control Module with SmartVac- DIRECT MARK
DEVICOR MEDICAL PRODUCTS, INC.
SCM12
In Commercial Distribution

  • 00841911101796 ()
DIRECT MARK GTIN

  • Mammographic stereotactic biopsy system
Footswitch
DEVICOR MEDICAL PRODUCTS, INC.
MFSW1
In Commercial Distribution

  • 00841911101765 ()
MFSW1

  • Mammographic stereotactic biopsy system
"Holster (tetherless vacuum-assisted biopsy system)"
DEVICOR MEDICAL PRODUCTS, INC.
MEH1
In Commercial Distribution

  • 00841911101703 ()


  • Mammographic stereotactic biopsy system
Stereotactic X-Ray Breast Biopsy Table System
DEVICOR MEDICAL PRODUCTS, INC.
MMT100
In Commercial Distribution

  • 00841911101581 ()


  • Mammographic stereotactic biopsy system
Variable Aperture Sleeve
DEVICOR MEDICAL PRODUCTS, INC.
VAS11
In Commercial Distribution

  • 10841911101243 ()
  • 00841911101246 ()

  • Needle Gauge: 11 Gauge
VAS11

  • Mammographic stereotactic biopsy system
Variable Aperture Sleeve
DEVICOR MEDICAL PRODUCTS, INC.
VAS08
In Commercial Distribution

  • 10841911101236 ()
  • 00841911101239 ()

  • Needle Gauge: 8 Gauge
VAS08

  • Mammographic stereotactic biopsy system
Universal Targeting Set - Long
DEVICOR MEDICAL PRODUCTS, INC.
MRU11X
In Commercial Distribution

  • 00841911101116 ()
  • 10841911101113 ()

  • Length: 145 Millimeter
  • Needle Gauge: 11 Gauge
MRU11X

  • Mammographic stereotactic biopsy system
Universal Targeting Set - Short
DEVICOR MEDICAL PRODUCTS, INC.
MRU11S
In Commercial Distribution

  • 00841911101109 ()
  • 10841911101106 ()

  • Length: 115 Millimeter
  • Needle Gauge: 11 Gauge
MRU11S

  • Mammographic stereotactic biopsy system
Universal Targeting Set - Long
DEVICOR MEDICAL PRODUCTS, INC.
MRU08X
In Commercial Distribution

  • 00841911101093 ()
  • 10841911101090 ()

  • Length: 145 Millimeter
  • Needle Gauge: 8 Gauge
MRU08X

  • Mammographic stereotactic biopsy system
Universal Targeting Set - Short
DEVICOR MEDICAL PRODUCTS, INC.
MRU08S
In Commercial Distribution

  • 00841911101086 ()
  • 10841911101083 ()

  • Length: 115 Millimeter
  • Needle Gauge: 8 Gauge
MRU08S

  • Mammographic stereotactic biopsy system
MR Targeting Set - Long
DEVICOR MEDICAL PRODUCTS, INC.
MRT11X
In Commercial Distribution

  • 00841911101079 ()
  • 10841911101076 ()

  • Length: 145 Millimeter
  • Needle Gauge: 11 Gauge
MRT11X

  • Mammographic stereotactic biopsy system
MR Targeting Set - Short
DEVICOR MEDICAL PRODUCTS, INC.
MRT11S
In Commercial Distribution

  • 00841911101062 ()
  • 10841911101069 ()

  • Length: 115 Millimeter
  • Needle Gauge: 11 Gauge
MRT11S

  • Mammographic stereotactic biopsy system
MR Targeting Set - Long
DEVICOR MEDICAL PRODUCTS, INC.
MRT08X
In Commercial Distribution

  • 00841911101055 ()
  • 10841911101052 ()

  • Length: 145 Millimeter
  • Needle Gauge: 8 Gauge
MRT08X

  • Mammographic stereotactic biopsy system
MR Targeting Set - Short
DEVICOR MEDICAL PRODUCTS, INC.
MRT08S
In Commercial Distribution

  • 00841911101048 ()

  • Height: 115 Millimeter
  • Needle Gauge: 8 Gauge
MRT08S

  • Mammographic stereotactic biopsy system
Holster (tetherless vacuum-assisted biopsy system) - CE
DEVICOR MEDICAL PRODUCTS, INC.
MEH1
In Commercial Distribution

  • 00841911100850 ()
MEH1

  • Mammographic stereotactic biopsy system
Stereotactic Holster - CE
DEVICOR MEDICAL PRODUCTS, INC.
MSTH1
In Commercial Distribution

  • 00841911100706 ()
MSTH1

  • Mammographic stereotactic biopsy system
Control Module - CE
DEVICOR MEDICAL PRODUCTS, INC.
MSCM1
In Commercial Distribution

  • 00841911100690 ()
MSCM1

  • Mammographic stereotactic biopsy system
Ultrasound Holster - CE
DEVICOR MEDICAL PRODUCTS, INC.
MHUSH1
In Commercial Distribution

  • 00841911100683 ()
MHUSH1

  • Mammographic stereotactic biopsy system
Remote Keypad
DEVICOR MEDICAL PRODUCTS, INC.
MHKEYP1
In Commercial Distribution

  • 00841911100676 ()


  • Mammographic stereotactic biopsy system
Footswitch
DEVICOR MEDICAL PRODUCTS, INC.
MFOOT1
In Commercial Distribution

  • 00841911100669 ()


  • Mammographic stereotactic biopsy system
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