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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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Modern Fertility Pregnancy Test 2ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599610 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
931
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008324 ()
991067S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
930
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008263 ()
991066S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
pNeuton Ventilator, model A
AIRON CORPORATION
A
In Commercial Distribution

  • 00853678006009 ()

  • Depth: 7.3 Inch
  • Width: 10.0 Inch
  • Height: 5.0 Inch
  • Weight: 6.5 Pound
20052

  • Portable pneumatic ventilator
The QT Scanner 2000 Model A is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator. The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
Qt Imaging, Inc.
A
In Commercial Distribution

  • 00852619008003 ()
100366

  • General-purpose ultrasound imaging system
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "A" is labeled for connections to electrodes 1-64.
NEURALYNX, INC.
-A
In Commercial Distribution

  • 00850011306369 ()
31-0602-0032

  • Electrical-only medical device connection cable, reusable
The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution

  • 00868924000038 ()


  • Short-wave diathermy treatment system, home-use
Light Weight Wheelchair
Bowhead Design Corporation
A
In Commercial Distribution

  • 00860013500900 ()


  • Push-rim manual wheelchair, non-bariatric
InnoVoyce VYLO Cart
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812180 ()
LC-00455

  • General/multiple surgical diode laser system
InnoVoyce VYLO Footswitch
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812111 ()
PRT-301009

  • General/multiple surgical diode laser system
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