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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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VIDAR SYSTEMS CORPORATION
MASTER CD, CLINICAL EXPRESS 6.1 BUILD 15
In Commercial Distribution

  • 00851194002147 ()
19206-006

  • Radiology DICOM image processing application software
PowerHeal, 4"x4" Single Layer, & Energel
Vomaris Wound Care, Inc.
4"x4" SL, 4"x4" CD & Energel
In Commercial Distribution

  • 00810198031492 ()
PSK-4040-03

  • Bioelectric wound dressing
Procellera Power Pack, 4"x4" Single Layer, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" SL, 4"x4" CD & Energel
In Commercial Distribution

  • 00810198030426 ()
VCK-0404-04

  • Bioelectric wound dressing
No Description
Slmp, LLC
(BTO) Sample CD 23 (1B12) Antibody (2ml)
In Commercial Distribution

  • 00810170552762 ()
SAM-MM20-2

  • CD23 cell marker IVD, antibody
CD23, Clone 1B12, 10mL
Slmp, LLC
(BTO) RTU CD 23 (1B12) Antibody (10ml)
In Commercial Distribution

  • 00810170550898 ()
MM20-10

  • CD23 cell marker IVD, antibody
Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5330 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5330 Sensors, and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533020 ()
BCE5330-2

  • Body-surface pressure mapping system
BRIT Lite 3.4.2 is an easy to use application for viewing DICOM images from a CD/DVD. In addition, it can be installed as a desktop application to view DICOM images from Roentgen Files (BRIT PACS).
Brit Systems, LLC
3.4.2
In Commercial Distribution

  • 00850631008360 ()


  • Radiology DICOM image processing application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Multi User License (up to 10 User) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A2
In Commercial Distribution

  • 07290110255428 ()
HASP-SW-K-NEMS-A-02

  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis, including support for NR via USB The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-2
In Commercial Distribution

  • 07290110254971 ()
HASP-SW-K-NH301-4-02

  • Electrocardiographic long-term ambulatory recording analyser
RScribe 12-Lead Multi-Channel Electrocardiograph - version 6, current software CD; No Acquisition Module; Adult and pediatric interpretation; Software kit; No power cord; No printer; No accessories; IEC 10 wire, 12-lead lead set with banana plugs; No connectivity
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094263022 ()
RSCRIBE-6EC-XXDBX

  • Electrocardiograph, professional, multichannel
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