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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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ERC 2P Laptop Assembly US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_US
In Commercial Distribution

  • 00887517969132 ()
ERC2P-LAPTOP_P_US

  • Portable computer
ERC 2P Laptop Assembly UK
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_UK
In Commercial Distribution

  • 00887517969125 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_UK

  • Portable computer
ERC 2P Laptop Assembly EU
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_EU
In Commercial Distribution

  • 00887517969118 ()

  • Tools/Instruments
ERC2P-LAPTOP_P_EU

  • Portable computer
ERC 2P Laptop Assembly AR
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC2P-LAPTOP_P_AR
In Commercial Distribution

  • 00887517969101 ()

  • Tool/Instrument
ERC2P-LAPTOP_P_AR

  • Portable computer
Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WIS4000
In Commercial Distribution

  • 00810000890040 ()
WIS4000

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027S
In Commercial Distribution

  • 00885556780879 ()
ROB10027S

  • Portable computer
REAL INTELLIGENCE TABLET
Smith & Nephew, Inc.
ROB10027
In Commercial Distribution

  • 00885556757451 ()
ROB10027

  • Portable computer
Tablet for use with the Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
WA021
Not in Commercial Distribution

  • 00627908080097 ()


  • Evoked-potential audiometer
Laptop computer for use with Aurix system (DI: 00627908080011). The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
11010
Not in Commercial Distribution

  • 00627908080042 ()


  • Evoked-potential audiometer
Cardinal Health; Crypto Giardia Control; Contains (1) 1.0mL Cryptosporidium + and (1) 1.0mL Giardia +; IVD
Cardinal Health 200, LLC
CH6870
In Commercial Distribution

  • 50885380096745 ()
  • 20885380096744 ()
  • 10885380096747 ()
CH6870

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical
CABLE 05409 ATAKR COMPUTER
MEDTRONIC, INC.
05409
In Commercial Distribution

  • 00643169135598 ()

  • Length: 10.0 Feet
  • Length: 305.0 Centimeter


  • Electrical-only medical device connection cable, reusable
COMPUTER NCCPU NOTEBOOK ROHS
MEDTRONIC XOMED, INC.
NCCPU
In Commercial Distribution

  • 00643169177710 ()


  • Nerve-locating system
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPULO
In Commercial Distribution

  • 00643169020191 ()


  • Nerve-locating system
COMPUTER 945NCCPUE4LO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPUE4LO
In Commercial Distribution

  • 00643169553088 ()


  • Nerve-locating system
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPULO
In Commercial Distribution

  • 00643169553071 ()


  • Nerve-locating system
COMPUTER 945NCCPUE4LO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPUE4LO
In Commercial Distribution

  • 00643169793873 ()


  • Nerve-locating system
COMPUTER 9734519R BRIDGESTONE REWORK
MEDTRONIC NAVIGATION, INC.
9734519R
In Commercial Distribution

  • 00613994763464 ()


  • Multi-purpose stereotactic surgery system
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
945NCCPULO
In Commercial Distribution

  • 00643169861459 ()


  • Nerve-locating system
CABLE 05409 ATAKR COMPUTER
MEDTRONIC, INC.
05409
In Commercial Distribution

  • 00681490024358 ()

  • Length: 10.0 Feet


  • Electrical-only medical device connection cable, reusable
Computer ComboLab Acquisition v7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682146029 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Computer CardioLab Acquisition v7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682146012 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
Computer Mac-Lab Acquisition v7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145985 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
SEEKER™ Personal Computer
BAEBIES, INC.
3428
In Commercial Distribution

  • 00819704020258 ()
3428

  • Multichannel clinical chemistry analyser IVD, laboratory
SEEKER™ Personal Computer
BAEBIES, INC.
3145
Not in Commercial Distribution

  • 00819704020241 ()
3145

  • Multichannel clinical chemistry analyser IVD, laboratory
SEEKER™ Personal Computer
BAEBIES, INC.
3132
Not in Commercial Distribution

  • 00819704020234 ()
3132

  • Multichannel clinical chemistry analyser IVD, laboratory
COMPUTER DIGITAL VIDEO SYSTEM
PENTAX OF AMERICA, INC.
7245D
In Commercial Distribution

  • 04961333242054 ()


  • Video cassette recorder
COMPUTER DIGITAL VIDEO SYSTEM
PENTAX OF AMERICA, INC.
7245C
Not in Commercial Distribution

  • 04961333231638 ()


  • Manometric gastrointestinal motility analysis system
AltiX AI.i ComboLab Computer
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278935687 ()
2400000-005

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
AltiX AI.i CardioLab Computer
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278935656 ()
2400000-004

  • Cardiac electrophysiology analysis system
Computer ComboLab Acquisition v8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278507051 ()
2300000-005

  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
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