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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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HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.
MEDROCK, INC
HR-001
In Commercial Distribution

  • 00860000412711 ()


  • External manual massager, clinical
The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
MESA BIOTECH, INC.
1028
In Commercial Distribution

  • B54010280 ()
1028

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
UltraSlim Digital, Red Light (635nm)
PHOTONICA USA, LLC
60008
In Commercial Distribution

  • 00860925000338 ()
60008

  • Low-intensity laser fat liquefaction system
Pulsed Electromagnetic Field Wrap Black Neck Wrap
Hi-Dow International Incorporated
HD-08D(TSG-D1)
In Commercial Distribution

  • 00851640007931 ()


  • Short-wave diathermy treatment system, home-use
Pulsed Electromagnetic Field Wrap,,SHOULDER WRAP Black
Hi-Dow International Incorporated
HD-08C(TSG-C1)
In Commercial Distribution

  • 00851640007924 ()


  • Short-wave diathermy treatment system, home-use
Pulsed Electromagnetic Field Wrap, Black, Knee Wrap
Hi-Dow International Incorporated
HD-08B(TSG-B1)
In Commercial Distribution

  • 00851640007917 ()


  • Short-wave diathermy treatment system, home-use
Pulsed Electromagnetic Field Wrap,,LUMBAR WRAP Black
Hi-Dow International Incorporated
HD-08A(TSG-A1)
In Commercial Distribution

  • 00851640007900 ()


  • Short-wave diathermy treatment system, home-use
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Caerus Corp.
Activ8 Foot
In Commercial Distribution

  • 00851979007619 ()


  • Hand-held deep-tissue electromagnetic stimulator
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Caerus Corp.
Activ8 Universal
In Commercial Distribution

  • 00851979007596 ()


  • Hand-held deep-tissue electromagnetic stimulator
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Caerus Corp.
Activ8 Elbow
In Commercial Distribution

  • 00851979007572 ()


  • Hand-held deep-tissue electromagnetic stimulator
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