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

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
CONTAINER 9735231 LEGACY TAPS / DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159011795 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER 9735218 SOLERA 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159011764 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159010545 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159010514 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159010491 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159008658 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159007422 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159007392 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159007361 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734444
In Commercial Distribution

  • 00653159007279 ()
9734444

  • Device sterilization/disinfection container, reusable
CONTAINER 9734863 SOLERA TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159011733 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159008719 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159008689 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159008559 ()
9734443

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159007262 ()
9734443

  • Device sterilization/disinfection container, reusable
AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
No Description
PRO-DEX, INC.
APD-1000-4
In Commercial Distribution

  • 00856482008436 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
PDCMF-1000-1
In Commercial Distribution

  • 00856482008252 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
PDSD-5000-2
In Commercial Distribution

  • 00856482008214 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-SC-003
In Commercial Distribution

  • 00856482008184 ()


  • Device sterilization/disinfection container, reusable
No Description
PRO-DEX, INC.
05.000.030
In Commercial Distribution

  • 00856482008023 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-BP-001S-1
In Commercial Distribution

  • 00856482008009 ()
  • 10856482008006 ()


  • Disposable battery pack
No Description
PRO-DEX, INC.
PDSD-5000-5
In Commercial Distribution

  • 00856482008290 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
PDCMF-SC-001
In Commercial Distribution

  • 00856482008276 ()


  • Device sterilization/disinfection container, reusable
No Description
PRO-DEX, INC.
PDSD-5000-6
In Commercial Distribution

  • 00856482008245 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
PDSD-5000-1
In Commercial Distribution

  • 00856482008207 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing many surgical procedures immediately. The SIT Kit provides a generic set of must-have instruments in a convenient vacuum-sealed bag ready for use. The SIT kit contains: A 5.5" Straight Crile Hemostat A 4.5" Straight Iris Scissors A 9.75" Medium Magill Forceps A 6" Mayo-Hegar needle driver, and A protective sterile field wrap
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006057 ()
HHSIT01

  • General surgical procedure kit, non-medicated, single-use
2.0mm x 229mm K-wire
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
WIR2-229
In Commercial Distribution

  • 00856719002237 ()

  • tool/instrument
WIR2-229

  • Manual wire driver
No Description
BIOMET SPINE LLC
731M0000
In Commercial Distribution

  • 00880304854901 ()

  • SCREW DRIVER
731M0000

  • Surgical screwdriver, reusable
No Description
BIOMET SPINE LLC
14-525031
In Commercial Distribution

  • 00880304881242 ()

  • PLUG STARTER W/ HANDLE
14-525031

  • Surgical screwdriver, reusable
No Description
BIOMET SPINE LLC
731M0010
In Commercial Distribution

  • 00880304855014 ()

  • STAB N GRAB DRIVER
731M0010

  • Surgical screwdriver, reusable
No Description
BIOMET SPINE LLC
731M0001
In Commercial Distribution

  • 00880304854895 ()

  • SHORT DRIVER
731M0001

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
14-450220
In Commercial Distribution

  • 00880304592544 ()
14-450220

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
14-450210
In Commercial Distribution

  • 00880304592537 ()
14-450210

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
14-450200
In Commercial Distribution

  • 00880304592513 ()
14-450200

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
110010424
In Commercial Distribution

  • 00880304568679 ()

  • 3.5MM
110010424

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
110003330
In Commercial Distribution

  • 00880304566651 ()

  • 3.5MM
110003330

  • Surgical screwdriver, reusable
OCC Fixed Angle DTS Driver
Seaspine Orthopedics Corporation
PC2-300030
In Commercial Distribution

  • 10889981307158 ()
PC2-300030

  • Orthopaedic implant driver
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