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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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actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution

  • B786SBM2AA2100 ()
SBM2AA210

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software
Esthet-X®flow Liquid Micro Hybrid, U, 20 Compula® Tips Refill Package
DENTSPLY INTERNATIONAL INC.
648115
In Commercial Distribution

  • D0026481151 ()
  • D0026481150 ()

  • Esthet-X®flow Liquid Micro Hybrid U, 20 Compula® Tips
  • Weight: 0.25 Gram
648115

  • Dental composite resin
Protect U Guard Non-Woven Dressing 9x30 cm
PROTECT U GUARD, LLC
P19122
In Commercial Distribution

  • B086291222 ()
  • B086091220 ()

  • Width: 9 Centimeter
  • Length: 30 Centimeter


  • Adhesive bandage
Protect U Guard Non-Woven Dressing 9x20cm
PROTECT U GUARD, LLC
P29121
In Commercial Distribution

  • B086291212 ()
  • B086091210 ()

  • Width: 9 Centimeter
  • Length: 20 Centimeter


  • Adhesive bandage
Protect U Guard Non-Woven Dressing 7x9cm
PROTECT U GUARD, LLC
P29120
In Commercial Distribution

  • B086291202 ()
  • B086091200 ()

  • Width: 7 Centimeter
  • Length: 9 Centimeter


  • Adhesive bandage
No Description
PROTECT U GUARD, LLC
P20502
In Commercial Distribution

  • B086205022 ()
  • B086205020 ()


  • Isolation gown, single-use
No Description
PROTECT U GUARD, LLC
P20501
In Commercial Distribution

  • B086205012 ()
  • B086205010 ()


  • Isolation gown, single-use
No Description
PROTECT U GUARD, LLC
P20401
In Commercial Distribution

  • B086204012 ()
  • B086204010 ()


  • Shoe cover, non-conductive, sterile
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