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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PLATE 015-258 SMALL RECTANGLE
MEDTRONIC PS MEDICAL, INC.
015-258
In Commercial Distribution

  • 00673978003399 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-257-C SQUARE SMALL RIGID
MEDTRONIC PS MEDICAL, INC.
015-257-C
In Commercial Distribution

  • 00673978003382 ()

  • Width: 10.7 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-257 SQUARE SMALL
MEDTRONIC PS MEDICAL, INC.
015-257
In Commercial Distribution

  • 00673978003375 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-255 SMALL X
MEDTRONIC PS MEDICAL, INC.
015-255
In Commercial Distribution

  • 00673978003368 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-247 STRAIGHT 2H X 2H 5MM
MEDTRONIC PS MEDICAL, INC.
015-247
In Commercial Distribution

  • 00673978003313 ()

  • Width: 5.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-246 STRAIGHT 2H X 2H 2.5MM
MEDTRONIC PS MEDICAL, INC.
015-246
In Commercial Distribution

  • 00673978003306 ()

  • Width: 2.5 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-237 Y 3H X 3H 5MM DOUBLE
MEDTRONIC PS MEDICAL, INC.
015-237
In Commercial Distribution

  • 00673978003283 ()

  • Width: 5.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
GRIDMESH 015-2010 SQUARE-RECTANGULAR
MEDTRONIC PS MEDICAL, INC.
015-2010
In Commercial Distribution

  • 00673978003207 ()

  • Width: 45.0 Millimeter
  • Length: 55.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
GRID 015-2001-5-C RIGID 11 X 7.5CM 5MM
MEDTRONIC PS MEDICAL, INC.
015-2001-5-C
In Commercial Distribution

  • 00673978003191 ()

  • Width: 75.0 Millimeter
  • Length: 115.0 Millimeter
  • Width: 5.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
GRIDMESH 015-2001-5 11CM X 7.5CM 5MM HCD
MEDTRONIC PS MEDICAL, INC.
015-2001-5
In Commercial Distribution

  • 00673978003184 ()

  • Width: 5.0 Millimeter
  • Width: 75.0 Millimeter
  • Length: 110.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
GRID 015-2001-4-C RIGID 11 X 7.5CM 4MM
MEDTRONIC PS MEDICAL, INC.
015-2001-4-C
In Commercial Distribution

  • 00673978003177 ()

  • Width: 75.0 Millimeter
  • Length: 115.0 Millimeter
  • Width: 4.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
GRIDMESH 015-2001-4 11CM X 7.5CM 4MM HCD
MEDTRONIC PS MEDICAL, INC.
015-2001-4
In Commercial Distribution

  • 00673978003160 ()

  • Width: 75.0 Millimeter
  • Width: 4.0 Millimeter
  • Length: 110.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-160 H 3H X 1H X 3H
MEDTRONIC PS MEDICAL, INC.
015-160
In Commercial Distribution

  • 00673978003122 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-042 STRAIGHT 1H X 1H 8MM
MEDTRONIC PS MEDICAL, INC.
015-042
In Commercial Distribution

  • 00673978002668 ()

  • Length: 8.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-040-C RIGID STRT 1H X 1H 4MM
MEDTRONIC PS MEDICAL, INC.
015-040-C
In Commercial Distribution

  • 00673978002644 ()

  • Length: 4.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-040 STRAIGHT 1H X 1H 4MM
MEDTRONIC PS MEDICAL, INC.
015-040
In Commercial Distribution

  • 00673978002637 ()

  • Length: 4.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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
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.
PDCMF-1000-1
In Commercial Distribution

  • 00856482008252 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, 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-5000-2
In Commercial Distribution

  • 00856482008214 ()


  • 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
No Description
PRO-DEX, INC.
APD-SC-003
In Commercial Distribution

  • 00856482008184 ()


  • Device sterilization/disinfection container, reusable
Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument.
INTEGRATED ORBITAL IMPLANTS INC
I00057
In Commercial Distribution

  • 00854066006236 ()


  • Surgical screwdriver, reusable
Slotted 90° Tubular Wrench x 10mm
Metalogix
900104
In Commercial Distribution

  • 00854641008112 ()

  • Slotted 90°
  • Diameter: 10mm
  • Length: 3.89 Inch


  • External orthopaedic fixation system, reusable
General Tray
Metalogix
900127-F
In Commercial Distribution

  • 00854641008099 ()

  • Height: 10.1 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
Instrument + Hardware Tray
Metalogix
900126-F
In Commercial Distribution

  • 00854641008082 ()

  • Height: 5.5 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
J/N-Plate Tray
Metalogix
900125-F
In Commercial Distribution

  • 00854641008075 ()

  • Height: 9.6 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
C/Footplate Tray
Metalogix
900124-F
In Commercial Distribution

  • 00854641008068 ()

  • Height: 10.1 Inch
  • Width: 10.3 Inch
  • Length: 20.9 Inch


  • External orthopaedic fixation system, reusable
Implant Tray
Metalogix
900123-F
In Commercial Distribution

  • 00854641008051 ()

  • Width: 10.3 Inch
  • Height: 5.8 Inch
  • Length: 20.9 Inch


  • External orthopaedic fixation system, reusable
Standard Wrench x 10mm
Metalogix
900106
In Commercial Distribution

  • 00854641008044 ()

  • Standard
  • Diameter: 10mm


  • External orthopaedic fixation system, reusable
Open End/Swivel End Wrench x 10mm
Metalogix
900105
In Commercial Distribution

  • 00854641008037 ()

  • Open End/Swivel End
  • Diameter: 10mm


  • External orthopaedic fixation system, reusable
Wire Tensioner x Ratcheting
Metalogix
900100
In Commercial Distribution

  • 00854641008020 ()


  • External orthopaedic fixation system, reusable
T-Handle Wrench x AO
Metalogix
900103
In Commercial Distribution

  • 00854641008013 ()


  • External orthopaedic fixation system, reusable
Trocar & Sheath 4-6mm
Metalogix
100404
In Commercial Distribution

  • 00854641008006 ()

  • 4-6mm


  • External orthopaedic fixation system, reusable
No Description
Unique Surgical
Ball Joint, Bayonet Connector
In Commercial Distribution

  • 00854515008538 ()


  • Drilling power tool attachment, basic
No Description
Unique Surgical
90 Degree, Bayonet Connector
In Commercial Distribution

  • 00854515008422 ()


  • Drilling power tool attachment, basic
No Description
Unique Surgical
45 Degree, Bayonet Connector
In Commercial Distribution

  • 00854515008415 ()


  • Drilling power tool attachment, basic
AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
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 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

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

  • 00653159008658 ()
9734863

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

  • 00653159008559 ()
9734443

  • Device sterilization/disinfection container, reusable
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