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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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MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution

  • 00812394021499 ()
40-00580-01

  • External defibrillator application software
MDLink SW 10.16
Zoll Medical Corporation
400621-046
In Commercial Distribution

400621-046

  • External defibrillator application software
Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01C
In Commercial Distribution

  • 00812394020539 ()
XAEDMGR01C

  • External defibrillator application software
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
New handle, Alligator, with spike, PE coated, Two Wire, 2.2*1800 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10122180
In Commercial Distribution

  • 16932503540640 ()
  • 06932503540643 ()
  • 26932503540647 ()
  • 36932503540644 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 180 Centimeter


  • Flexible endoscopic biopsy forceps, single-use
Nexstim NBS Black Head Tracker (box of 4), new part list NX103355
Nexstim Oyj
NX92465
In Commercial Distribution

  • 06430063200125 ()
NX103377

  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph
Note: KS2-SSLARGEUNSC is new part number for KS2SSLARGEUNSCE. Product did not change.
King Systems Corporation
KS2-SSLARGEUNSC
Not in Commercial Distribution

  • 00612649176093 ()
  • 00612649205014 ()

  • Large
KS2-SSLARGEUNSC

  • Anaesthesia face mask, single-use
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution

  • 00841709118067 ()


  • Electrocardiographic long-term ambulatory recording analyser
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, 2X-Large
TRONEX INTERNATIONAL, INC.
9770-40
In Commercial Distribution

  • 00097604977050 ()
  • 10097604977057 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, Extra-Large
TRONEX INTERNATIONAL, INC.
9770-35
In Commercial Distribution

  • 00097604977043 ()
  • 10097604977040 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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