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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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ManaFlexx 2 - 00850998008089

The ManaFlexx 2 delivers electric pulse generated to the user’s body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. For Prescription Use: TENS: ManaFlexx2 (MF002-RX) is intended for the following use:- Symptomatic relief and management of chronic, intractable pain- Adjunctive treatment for post-surgical and post-trauma acute pain- Relief of pain associated with arthritis PMS/NMES: ManaFlexx2 (MF002-RX) is intended for the following use:- Temporary relaxation of muscle spasm- Prevention or retardation of disuse atrophy- Muscle re-education- Maintaining or increasing range of motion- Increase of local blood flow in the treatment area- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscle
Manamed, Inc.
MF002-RX
In Commercial Distribution

  • 00850998008089 ()
MF002-RX

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Paragon 2 - 00851354007159

Paragon Mobile with 14 x 17 Wireless Panel
MERIDIAN MEDICAL SYSTEMS, LLC
RT312
Not in Commercial Distribution

  • 00851354007159 ()


  • Mobile basic diagnostic x-ray system, digital

Cardius 2 - 00850816007065

No Description
DIGIRAD CORPORATION
Mobile XPOL
In Commercial Distribution

  • 00850816007065 ()


  • SPECT system, annular detector array

Cardius 2 - 00850816007058

No Description
DIGIRAD CORPORATION
XPOD International
In Commercial Distribution

  • 00850816007058 ()


  • SPECT system, annular detector array

Cardius 2 - 00850816007041

No Description
DIGIRAD CORPORATION
Mobile XPOD
In Commercial Distribution

  • 00850816007041 ()


  • SPECT system, annular detector array

Cardius 2 - 00850816007034

No Description
DIGIRAD CORPORATION
XPOD
In Commercial Distribution

  • 00850816007034 ()


  • SPECT system, annular detector array

ProSim 2 - 00850540007089

Vital Signs Patient Simulator
FLUKE ELECTRONICS CORPORATION
PROSIM 2
In Commercial Distribution

  • 00850540007089 ()
4318341

  • Multi-parameter device tester

KneeAlign 2 - 00851977007475

Calf Spring, 165mm
Orthalign, Inc.
401500
In Commercial Distribution

  • 00851977007475 ()
401500

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007468

Probe, Midline, Low-Profile, Left
Orthalign, Inc.
401645
In Commercial Distribution

  • 00851977007468 ()
401645

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007451

Probe, Midline, Low-Profile, Right
Orthalign, Inc.
401644
In Commercial Distribution

  • 00851977007451 ()
401644

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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