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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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The Vibratory Sensory Analyzer VSA-3000 is a computerized device for the quantitative assessment of large nerve fiber dysfunctions, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration. The Device includes: main unit, at least one probe and accessories.
MEDOC LTD.
VSA-3000
In Commercial Distribution

  • 07290103039509 ()
  • 07290103039004 ()
MO 00003

  • Vibratory biothesiometer
No Description
ALTIMATE MEDICAL INC.
Bantam Medium
In Commercial Distribution

  • 10858921006055 ()


  • Electric stander
  • Manual stander
No Description
ALTIMATE MEDICAL INC.
Evolv XT
In Commercial Distribution

  • 10858921006024 ()


  • Electric stander
  • Manual stander
No Description
ALTIMATE MEDICAL INC.
Evolv Large
In Commercial Distribution

  • 10858921006017 ()


  • Manual stander
  • Electric stander
No Description
ALTIMATE MEDICAL INC.
Evolv Medium
In Commercial Distribution

  • 10858921006000 ()


  • Manual stander
  • Electric stander
The MD-710 ("Relax8") is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The MD-710 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. The MD-710 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. MD-710 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MD-710 (Relax8)
In Commercial Distribution

  • 07290016986129 ()


  • Mental health/function therapeutic software, screen-viewed
  • Hypnotherapy virtual reality software
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
401020
In Commercial Distribution

  • 00657498000731 ()
401020

  • Single-channel clinical chemistry analyser IVD, point-of-care
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.
STANBIO LABORATORY, L.P.
401010
In Commercial Distribution

  • 00657498000090 ()
  • 00657498001868 ()
401010

  • Single-channel clinical chemistry analyser IVD, point-of-care
The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.
STANBIO LABORATORY, L.P.
400400
In Commercial Distribution

  • 00657498000083 ()
400400

  • Single-channel clinical chemistry analyser IVD, point-of-care
No Description
BENCO DENTAL SUPPLY CO.
4390-992
In Commercial Distribution

  • 00366975033864 ()


  • Periodontal probe, reusable
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