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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A combination centrifuge and reader for IH gel cards
Bio-Rad Medical Diagnostics GmbH
001200
In Commercial Distribution

  • 07611969205486 ()
001200

  • Immunohaematology/blood bank analyser IVD, semi-automated
Processes DNA sample data files of Class I and Class II Human Leukocyte Antigens (HLA) for analysis and HLA allele assignment by comparison to the IMGT/HLA database with uTYPE. The sample data files are generated from samples processed with SeCore™ SBT Sequencing kits or GSSP SBT Sequencing kits and the Applied Biosystems Genetic Analyzer.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021765 ()
539993

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system
ONE LAMBDA, INC.
UTPCDX-PGR
In Commercial Distribution

  • 00812117016849 ()
UTPCDX-PGR

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.
COMMWELL RESEARCH & DEVELOPMENT LTD.
PhysioGlove ET System
In Commercial Distribution

  • 07290012672026 ()
5-056-00

  • Multichannel electrocardiograph, noninterpretive
An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity. [i.e., an electrocardiogram (ECG) for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of the 12-lead recording of the same heartbeat. It records data in electronic form for later analysis by software or a healthcare professional.
COMMWELL RESEARCH & DEVELOPMENT LTD.
ES-ECG System
In Commercial Distribution

  • 07290012672019 ()
5-045-00

  • Multichannel electrocardiograph, noninterpretive
K-WIRE, 550MM, OLIVE TL-HEX STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242512752 ()

  • Length: 550 Millimeter
99-54-1750

  • Orthopaedic bone wire
K-WIRE, 450MM, NO OLIVE TL-HEX STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242512745 ()

  • Length: 450 Millimeter
99-54-1650

  • Orthopaedic bone wire
5/8 RING, 220MM, TL-HEX STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242510772 ()

  • Internal diameter 220 mm
  • Open ring approx 5/8 circumnference
99-56-21080

  • External orthopaedic fixation system, single-use, sterile
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation
PHYSIQ, INC
Model C
In Commercial Distribution

  • 00860004366294 ()


  • Electrocardiography telemetric monitoring system
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation.
PHYSIQ, INC
Model B
In Commercial Distribution

  • 00860004366287 ()


  • Electrocardiography telemetric monitoring system
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