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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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K-wire - 00856719002237

2.0mm x 229mm K-wire
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
WIR2-229
In Commercial Distribution

  • 00856719002237 ()

  • tool/instrument
WIR2-229

  • Manual wire driver

MISHA® Torque Limiting Driver - 00856047005917

No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use

Atlas Pro Driver Battery Pack, Sterile - 00856482008009

No Description
PRO-DEX, INC.
APD-BP-001S-1
In Commercial Distribution

  • 00856482008009 ()
  • 10856482008006 ()


  • Disposable battery pack

Universal SmartECG - 00857175006173

The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via a USB connection. The ECG amplifier detects electrical impulses from the patient and coverts them into a digital signal that can be displayed and recorded on the computer. The ECG system consists of a 12-lead ECG, multi-language Office Medic Software and VectraplexECG, a UL 60950 compliant host computer and accessories. The 12-lead ECG includes an analog front end designed to detect, amplify, filter, and output biopotential measurements in real time, a microprocessor to communicate and control the analog front end and system, short circuit protection, ESD protection, defibrillation isolation and protection, a green indication LED, 10 leadwires, lead off detection, USB communication to PC and Office Medic or VectraplexECG, and bootloader. The device is powered by the USB connector and is regulated to two separate supplies, a 3.3V digital supply and a 3.3V analog supply to respectively power the digital and analog circuitry. The 12-lead ECG outputs ECG waveform information via USB to the Office Medic or VectraplexECG Software that translates, filters, analyzes, and displays the ECG waveform in real time. The hardware contains an FTDI USB UART translator chip to install required USB drivers to the PC and allow appropriate data conversion to the PC during ECG measurement.
VECTRACOR INC
AHA
In Commercial Distribution

  • 00857175006173 ()
Z-7000-0500

  • Electrocardiograph, professional, multichannel

CASE MEDICAL - 00653159011795

CONTAINER 9735231 LEGACY TAPS / DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159011795 ()
9735231

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159011764

CONTAINER 9735218 SOLERA 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159011764 ()
9735218

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159011733

CONTAINER 9734863 SOLERA TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159011733 ()
9734863

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010545

CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159010545 ()
9735231

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010514

CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159010514 ()
9735218

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159010491

CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159010491 ()
9734863

  • Device sterilization/disinfection container, reusable
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