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
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183312
In Commercial Distribution

  • 04056869002408 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183311
In Commercial Distribution

  • 04056869002392 ()


  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10273987
In Commercial Distribution

  • 04056869002170 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10273985
In Commercial Distribution

  • 04056869002163 ()


  • SPECT system application software
  • PET system application software
The Corowell COVID-19 Symptom Screening Test is intended to objectively testing of the sense of smell. It enables the identification of subjects whose olfactory perception is deviating, restricted or newly got lost. The Corowell COVID-19 Symptom Screening Test is a device for home use. The Corowell COVID-19 Symptom Screening Test can be performed self-administered by the subject. The target population is adults over 18 years of age.
MKG Consulting UG (haftungsbeschränkt)
1
In Commercial Distribution

  • 14260698980012 ()
  • 04260698980015 ()
  • 24260698980019 ()
  • 34260698980016 ()
  • 04260698980022 ()
  • 14260698980029 ()
  • 24260698980026 ()
  • 04260698980046 ()
  • 04260698980053 ()
001

  • Olfactory test stick
The Odor Quartet is a training kit consisting of 4 olfactory pens used to improve the sense of smell. The effect of the olfactory training is based both on stimulation of the olfactory mucosa in the nose and on an improvement of sensory impressions in the brain. The Odor Quartet consists of 4 olfactory pens, which release different scents: i.e. lemon, rose, clove and eucalyptus.
Burghart Messtechnik GmbH
LA-13-00434
In Commercial Distribution

  • 04260676240209 ()
LA-13-00434

  • Olfactory test stick
The Screening 12 Test is intended to be used for examination of smell disorders on humans. The test result can be used to differentiate between Normosmia, Hyposmia, and Anosmia, if the patient is cooperative.
Burghart Messtechnik GmbH
LA-13-00437
In Commercial Distribution

  • 04260676240155 ()
LA-13-00437

  • Olfactory test stick
The Screening 12 test is intended to be used for examination of smell disorders on humans. The test results can be used to differentiate between Normosmia, Hyposmia and Anosmia, if the patient is cooperative.
Burghart Messtechnik GmbH
LA-13-00436
In Commercial Distribution

  • 04260676240148 ()
LA-13-00436

  • Olfactory test stick
Refill Kit for the Extended Test: The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.
Burghart Messtechnik GmbH
LA-13-00433
In Commercial Distribution

  • 04260676240131 ()
LA-13-00433

  • Olfactory test stick
The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.
Burghart Messtechnik GmbH
LA-13-00435
In Commercial Distribution

  • 04260676240124 ()
LA-13-00435

  • Olfactory test stick
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