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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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v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647039 ()
302.4018

  • Radiology DICOM image processing application software
EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026635046 ()


  • Nucleic acid sample preparation instrument IVD
EMAG software (virtual) version 1.3 also called SP3
BIOMERIEUX SA
1.3
In Commercial Distribution

  • 03573026613358 ()


  • Nucleic acid sample preparation instrument IVD
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for: - Endoanal ultrasound (trans-rectal ultrasound / echography) - Anoscopy exams - Manometry exams
THD SPA
THD Procto Software
In Commercial Distribution

  • 08033737713037 ()
760004

  • Ultrasound imaging system application software
Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
EB NEURO SPA
B8640053000
In Commercial Distribution

  • 08056446900642 ()


  • Bioelectrical signal analysis software
UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022496 ()
790111

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
V2.2.0 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.2.0
In Commercial Distribution

  • 00814905020137 ()


  • Parenteral-nutrition management software
V2.1.3 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.3
In Commercial Distribution

  • 00814905020021 ()


  • Parenteral-nutrition management software
V2.1.2 Operating Software for the Codonics Safe Label System® 500i Point of Care Station
CODONICS INC.
2.1.2
In Commercial Distribution

  • 00814905020014 ()


  • Parenteral-nutrition management software
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