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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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None - 00886874110003

ENDOSCOPE
INTUITIVE SURGICAL, INC.
311464
In Commercial Distribution

  • 00886874110003 ()

  • Outer Diameter: 12 Millimeter
  • Angle: 0 degree


  • Rigid optical laparoscope

Single-Site - 00886874112014

ENDOSCOPE PORT
INTUITIVE SURGICAL, INC.
428065
In Commercial Distribution

  • 30886874112015 ()
  • 10886874112011 ()
  • 00886874112014 ()

  • Lumen/Inner Diameter: 8.5 Millimeter


  • Laparoscopic multi-instrument access port, single-use

Norav 1200 Series PC-ECG - 07290110252793

Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution

  • 07290110252793 ()
HASP-SW-K-S2I1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer

BOND - 09349458004859

The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Controller (6.0/W10 loT)
In Commercial Distribution

  • 09349458004859 ()
S21.4621

  • Microscope slide stainer IVD

ShuntCheck III DAQ - 00865435000328

Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit

BACT/ALERT® 3D CONTROL MODULE - 03573026049522

The BacT/ALERT 3D Control Module enables up to 6 incubator modules to be operated from one integrated touchscreen computer.
BIOMERIEUX , INC.
210147
In Commercial Distribution

  • 03573026049522 ()


  • Blood culture analyser IVD

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

Guardian Programmer Model PROG-004 - 00850012625162

PROG-004 Kit (US)
Avertix Medical Inc.
0217-2100-004#P18
In Commercial Distribution

  • 00850012625162 ()
0217-2100-004#P18

  • Implantable cardiac device management application software

AngelMed Guardian Programmer PROG-003 Carrying Case - 00850012625148

PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution

  • 00850012625148 ()
0204-2100-079#P10

  • Implantable cardiac device management application software

AngelMed Guardian Programmer Application User's Manual CD - 00850012625131

PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution

  • 00850012625131 ()
0204-2100-073#P16

  • Implantable cardiac device management application software
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