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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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Hearing device app
AMPLIFON SPA
5.0.2
In Commercial Distribution

  • 08059606110356 ()


  • Hearing aid/implant system remote control
No Description
Nox Medical ehf.
NOX-NOXTURNAL_APP
Not in Commercial Distribution

  • 15694311110019 ()
536210

  • Sleep disorder interpretive software, professional-only
The ManaFlow, part numbers MFLOW51 and MFLOW52, is comprised of a below knee gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted. • Treatment of lymphedema • Treatment of chronic venous insufficiency • Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers • Reducing venous leg ulcer healing time • Reducing edema due to venous stasis • Enhancing venous return The device is intended for home, and hospital use.
Manamed, Inc.
MFLOW51
In Commercial Distribution

  • 00850998008270 ()
MFLOW51

  • Intermittent venous compression system pump
The ManaFlow 51 full leg is pre-set to the default setting of 50 mmHg and cannot be adjusted. The indications for ManaFlow 51 are • Treatment of lymphedema • Treatment of chronic venous insufficiency • Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers • Reducing venous leg ulcer healing time • Reducing edema due to venous stasis • Enhancing venous return The device is intended for home, and hospital use.
Manamed, Inc.
MFLOW51LEG
In Commercial Distribution

  • 00810113682259 ()
MFLOW51LEG

  • Sequential venous compression system inflator
No Description
CareDx AB
101.561-03u
In Commercial Distribution

  • 07340035504108 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
No Description
CareDx AB
101.561-24u
In Commercial Distribution

  • 07340035504085 ()


  • HLA class I antigen tissue typing IVD, kit, multiplex
PROTOCOL SACCOMANNO FLUID 1GAL
FISHER SCIENTIFIC COMPANY L.L.C.
11002232
In Commercial Distribution

  • 20613647028623 ()
  • 00613647028629 ()
  • 10613647028626 ()
11002232

  • Saccamanno solution IVD
Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mucolexx™
In Commercial Distribution

  • 00673693235914 ()
9990375

  • Saccamanno solution IVD
Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mucolexx™
In Commercial Distribution

  • 00673693235907 ()
9990371

  • Saccamanno solution IVD
Fixation is vital in the stabilization and maintenance of the existing form and structure of all cellular constituents. The fixative, when applied, coats, and protects cells with a water-soluble film. This film, derived from resin, coats cell preparations to preserve nuclear detail for microscopic examination and diagnosis.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mucolexx™
In Commercial Distribution

  • 00673693235891 ()
9990370

  • Saccamanno solution IVD
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