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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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Sarstedt Aktiengesellschaft & Co.KG
97.8710.602
In Commercial Distribution

  • 04038917968560 ()
97.8710.602

  • Cryopreserved blood/tissue thawing unit
No Description
Sarstedt Aktiengesellschaft & Co.KG
97.8710.502
In Commercial Distribution

  • 04038917968324 ()
97.8710.502

  • Cryopreserved blood/tissue thawing unit
PLEGIOX Heat Exchanger, SOFTLINE coated, Sterile. The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature-controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
BO-CHX 30, SOFTLINE, Sterile
Not in Commercial Distribution

  • 04037691229591 ()
  • 04037691229584 ()
70103.4981

  • Cardiopulmonary bypass system heat exchanger, reusable
The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
CHX 30, Non-coated, Sterile
Not in Commercial Distribution

  • 04037691180038 ()
  • 04058863052267 ()

  • Total Volume: 46.885 Liter
  • Weight: 0.35 Kilogram
70103.2522

  • Cardiopulmonary bypass system heat exchanger, reusable
Paraffin Heat Therapy Unit
HYGENIC CORPORATION, THE
24050
Not in Commercial Distribution

  • 30087453240505 ()
  • 00087453240504 ()
24050

  • Physical therapy paraffin wax bath
The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
61043
In Commercial Distribution

  • 00810137610436 ()


  • Blue/red/infrared phototherapy lamp
The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits energy for dermatology to treat wrinkles within the periorbital region. The device usesfour types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the mainunit, USB cable cord and velcro straps and removable eye protection. There is a total of 40 LEDs toprovide a power intensity of about 65 mW/cm?. The device has only one button to turn on/off.The user wears the device on their eye area for the treatment, and the device will shut down automatically
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20N
In Commercial Distribution

  • 00810137610429 ()


  • Blue/red/infrared phototherapy lamp
FAQ™ 200 Plus is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Black
In Commercial Distribution

  • 07640260120662 ()


  • Blue/red/infrared phototherapy lamp
FAQ™ 202 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Black
In Commercial Distribution

  • 07640260120174 ()


  • Blue/red/infrared phototherapy lamp
FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Pink Ruby
In Commercial Distribution

  • 07640260120167 ()


  • Blue/red/infrared phototherapy lamp
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