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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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NuMed Silver Bordered Foam 4x4 is made up of a PU Antibacterial polyurethane foam, polyvinyl alchohal, silver sulfate and silver chloride. It is a highly absorbent foam dressing with 0.35-0.40mg/cm3 ionic silver as the active component. This dressing provides an optimal moist wound healing enviroment, combining an effective antibacterial activity and is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.
Numed Industries, LLC
NM1010SBF
In Commercial Distribution

  • 00819123011042 ()
  • 00819123011059 ()

  • Width: 4 Inch
  • Length: 4 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
NuMed Silver Bordered Foam 2x2 is made up of a PU Antibacterial polyurethane foam, polyvinyl alchohal, silver sulfate and silver chloride. It is a highly absorbent foam dressing with 0.35-0.40mg/cm3 ionic silver as the active component. This dressing provides an optimal moist wound healing enviroment, combining an effective antibacterial activity and is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.
Numed Industries, LLC
NM5050SBF
In Commercial Distribution

  • 00819123011011 ()
  • 00819123011028 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
NuMed Silver Foam 4x4 is made up of a PU Antibacterial polyurethane foam, polyvinyl alchohal, silver sulfate and silver chloride. It is a highly absorbent foam dressing with 0.35-0.40mg/cm3 ionic silver as the active component. This dressing provides an optimal moist wound healing enviroment, combining an effective antibacterial activity and is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.
Numed Industries, LLC
NM1010SF
In Commercial Distribution

  • 00819123010984 ()
  • 00819123010991 ()

  • Width: 4 Inch
  • Length: 4 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
NuMed Silver Foam 2x2 is made up of a PU Antibacterial polyurethane foam, polyvinyl alchohal, silver sulfate and silver chloride. It is a highly absorbent foam dressing with 0.35-0.40mg/cm3 ionic silver as the active component. This dressing provides an optimal moist wound healing enviroment, combining an effective antibacterial activity and is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.
Numed Industries, LLC
NM5050SF
In Commercial Distribution

  • 00819123010953 ()
  • 00819123010960 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M3
In Commercial Distribution

  • 10381780040415 ()


  • Ultrasonic surgical system torque wrench, single-use
Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M2
Not in Commercial Distribution

  • 10381780040408 ()


  • Ultrasonic surgical system torque wrench, single-use
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. 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

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. 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.
v1.0
Not in Commercial Distribution

  • B553TEMPOINSIGHTS100 ()


  • Home pharmaceutical management support software
The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
TENS PLUS INDUSTRIAL COMPANY
ED3930
In Commercial Distribution

  • 14897076720092 ()
ED3930

  • Analgesic transcutaneous electrical nerve stimulation system
Vashe Wound Solution is a skin, wound, burn cleansing solution that is for use for debridement, irrigation, physical disruption of biofilm and removal of microorganisms. This is the 1 L (34 fl oz) size with the flip top cap.
URGO MEDICAL NORTH AMERICA, LLC
00322
In Commercial Distribution

  • 10851383003228 ()
  • 00851383003221 ()

  • Total Volume: 1 Liter
00322

  • Antimicrobial wound irrigation solution
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