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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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Tommie Copper Neck Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-ZLD-46-NP
In Commercial Distribution

  • 00843041125840 ()


  • Red/infrared light phototherapy unit
Tommie Copper Joint Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-HX-60B-JW
In Commercial Distribution

  • 00843041125833 ()


  • Red/infrared light phototherapy unit
Tommie Copper Back Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-ZLD-60V-BW
In Commercial Distribution

  • 00843041125826 ()


  • Red/infrared light phototherapy unit
The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environment. It provides extra warmth for Infant patients when they are out of the bassinet for examination, bathing, weighing, feeding, or minor procedures.Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows the user to confirm a safe minimum distance from the heat source, while the intensity control allows the user to set just the right level of radiant heat.
NATUS MEDICAL INCORPORATED
Model 45
In Commercial Distribution

  • 00382830047036 ()
56845

  • Infant warmer
The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environment. It provides extra warmth for Infant patients when they are out of the bassinet for examination, bathing, weighing, feeding, or minor procedures.Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows the user to confirm a safe minimum distance from the heat source, while the intensity control allows the user to set just the right level of radiant heat.
NATUS MEDICAL INCORPORATED
Model 41
In Commercial Distribution

  • 00382830005470 ()
56841

  • Infant warmer
"The Olympic Warm-Lamp Model 31 is a source of controllable heat in the patient care environment. It provides extra warmth for infant patients when out of the bassinet for examination, bathing, weighing, feeding, or minor procedures. Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows you to confirm a safe minimum distance from the heat source, while the intensity control allows you to set just the right level of radiant heat. feeding, or minor procedures."
NATUS MEDICAL INCORPORATED
Model 31
In Commercial Distribution

  • 00382830005463 ()
56831

  • Infant warmer
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
Life Beam
In Commercial Distribution

  • 08809922440060 ()


  • Red/infrared light phototherapy unit
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED-Pro Mini
In Commercial Distribution

  • 08809922440053 ()


  • Red/infrared light phototherapy unit
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red) and 850nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED
In Commercial Distribution

  • 08809922440046 ()


  • Red/infrared light phototherapy unit
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED-Pro
In Commercial Distribution

  • 08809922440039 ()


  • Red/infrared light phototherapy unit
a cosmetic outlook improved version if compare with the previous ABPT1003 device. so, this is a Mark II version with slight change to the machine outlook.
APPLIED BIOPHOTONICS LIMITED
ABPT1003-2
In Commercial Distribution

  • 04719873240029 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
APPLIED BIOPHOTONICS LIMITED
ABPT1003
In Commercial Distribution

  • 04719873240012 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the Richmar console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
MCT 507
In Commercial Distribution

  • 00628451918417 ()
  • 00628451918400 ()
  • 60628451918419 ()
  • 20628451918411 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
0455
In Commercial Distribution

  • 00628451918387 ()
  • 00628451918394 ()
  • 90628451918397 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit.
MedX Health Corp
LCS450
In Commercial Distribution

  • 00628451918356 ()
  • 00628451918226 ()


  • Musculoskeletal/physical therapy laser, professional
The Oralase Portable Laser, LPS200, delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. This device is the main reference for identification and traceability for MedX Health kit Item# 0910 This product is registered to show its UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
LPS200
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918349 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX SLD Light diode Cluster is used together with the MedX Home console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.
MedX Health Corp
MCT1000
In Commercial Distribution

  • 00628451918332 ()
  • 00628451918172 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identification and traceability, and part of the kit for MedX item number #2130. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
2030
In Commercial Distribution

  • 00628451918165 ()
  • 00628451918325 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
201
In Commercial Distribution

  • 00628451918240 ()
  • 00628451918318 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116. LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
450
In Commercial Distribution

  • 00628451918301 ()
  • 00628451918134 ()


  • Musculoskeletal/physical therapy laser, professional
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