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
MICROPORT CRM SRL
V3.10 UPG TO USB COM
In Commercial Distribution

  • 08031527014944 ()


  • Electrocardiographic long-term ambulatory recording analyser
ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1 in. display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack paper - A4 with spacer for writer tray); current software; UK power cord; IEC 10 wire, 12-lead lead set with banana plugs; Adult and pediatric interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); Ethernet LAN + WLAN (WPA2) + USBD; Standard storage (up to 40 ECGs); DICOM (Bidirectional com
WELCH ALLYN, INC.
901132
In Commercial Distribution

  • 00732094266320 ()
ELI280-DCB-AAFAD

  • Electrocardiograph, professional, multichannel
No Description
FORUM BRANDS, LLC
12ct Ultra Thin Lubricated Condoms - .COM
In Commercial Distribution

  • 00851617007889 ()
  • 00851617007339 ()
  • 00851617007766 ()


  • Basic male condom, Hevea-latex
No Description
Natus Medical Denmark ApS
1096, SA CLINI W/ PRIN,COM US
In Commercial Distribution

  • 05713315005664 ()
8-04-16047

  • Impedance audiometer
No Description
Natus Medical Denmark ApS
1096,SA, DIAG W/ PRIN, COM US
In Commercial Distribution

  • 05713315005619 ()
8-04-16042

  • Impedance audiometer
No Description
Natus Medical Denmark ApS
1096, SA,CLINI W/O PRIN, COM US
In Commercial Distribution

  • 05713315005671 ()
8-04-16048

  • Impedance audiometer
No Description
Natus Medical Denmark ApS
1096,SA, DIAG W/O PRIN,COM US
In Commercial Distribution

  • 05713315005633 ()
8-04-16044

  • Impedance audiometer
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution

  • B679SLP4H0 ()
SLP4H

  • Musculoskeletal/physical therapy laser, professional
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