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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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No Description
Roche Diagnostics GmbH
4499107190
Not in Commercial Distribution

  • 04015630997657 ()
4499107190

  • Phencyclidine (PCP) IVD, kit, chemiluminescent immunoassay
NuMed Silver Alginate Rope Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days.
Numed Industries, LLC
B-NM3530SAD
In Commercial Distribution

  • 00819123010694 ()
  • 10819123010691 ()

  • Width: .35 Inch
  • Length: 12 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
NuMed Silver Alginate 4x5 Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days.
Numed Industries, LLC
B-NM1012SAD
In Commercial Distribution

  • 00819123010687 ()
  • 10819123010684 ()

  • Length: 4 Inch
  • Width: 5 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
NuMed Silver Alginate 2x2 Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days.
Numed Industries, LLC
B-NM5050SAD
In Commercial Distribution

  • 00819123010670 ()
  • 10819123010677 ()

  • Length: 2 Inch
  • Width: 2 Inch


  • Exudate-absorbent dressing, non-gel, antimicrobial
The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
NeuroStim
In Commercial Distribution

  • B960NSS201 ()
  • B960NSS2011 ()
  • B960NSS2012 ()
  • B327NSS201 ()
  • B960NSS2013 ()
01-1021

  • Acupuncture electrical stimulation system
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013406 ()
1151300010

  • Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013383 ()
1151306010

  • Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues: • Documentation of weight changes • Documentation of energy expenditure and energy reserves • Documentation of cardiometabolic risk • Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy • Documentation of a patient’s fluids status and documentation of changes in fluids • Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution

  • 04012030013376 ()
1151303010

  • Medical equipment clinical data interfacing software
No Description
Vista Dental
9007101
In Commercial Distribution

  • 10818207024968 ()


  • Gingival retraction solution
No Description
Vista Dental
10818207024937
In Commercial Distribution

  • 10818207024937 ()


  • Root canal cleaning solution
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