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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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Prevahex Antimicrobial Transparent Film Dressing
Entrotech Life Sciences, LLC
1484CH
In Commercial Distribution

  • B5591484CH00 ()
1484CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 2.375 IN x 2.75 IN, 400 Dressings/Case, 1484CH
Entrotech Life Sciences, LLC
1484BOX
In Commercial Distribution

  • B5591484BOX1 ()
  • B5591484CH0 ()
  • B5591484CASE3 ()
1484BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressing
Entrotech Life Sciences, LLC
1483CH
In Commercial Distribution

  • B5591483CH00 ()
1483CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 1.75 IN x 1.75 IN, 400 Dressings/Case, 1483CH
Entrotech Life Sciences, LLC
1483BOX
In Commercial Distribution

  • B5591483BOX1 ()
  • B5591483CH0 ()
  • B5591483CASE3 ()
1483BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient device.
JTECH Medical
CT012
In Commercial Distribution

  • G041CT0120 ()


  • Joint/spinal manipulator, mechanical
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient.
JTECH Medical
CT006
In Commercial Distribution

  • G041CT0060 ()


  • Joint/spinal manipulator, mechanical
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient.
JTECH Medical
CT001
In Commercial Distribution

  • G041CT0010 ()


  • Joint/spinal manipulator, mechanical
EMED Soluble Hemostatic Gauze
EMED TECHNOLOGIES CORPORATION
EHEM42-1
Not in Commercial Distribution

  • 00817708022940 ()
  • 00817708022933 ()
EHEM42-1

  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
ZyFuse HA Compression Screw, 5mm x 30mm
GLOBUS MEDICAL, INC.
147.530S
In Commercial Distribution

  • 00889095341348 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5 Millimeter


  • Trans-facet-screw internal spinal fixation system, sterile
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