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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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Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-FAACB
Not in Commercial Distribution

  • 00812345027754 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-CXXXX
Not in Commercial Distribution

  • 00812345027747 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-AAB-CXXXA
Not in Commercial Distribution

  • 00812345027730 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution

  • 00812345023459 ()


  • Patient health record information system
No Description
HiCat GmbH
6543651
In Commercial Distribution

  • B06965436510 ()


  • Diagnostic x-ray digital imaging system workstation
ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343012 ()


  • Specimen information management system IVD
The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343005 ()


  • Specimen information management system IVD
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution

  • 00817100020490 ()


  • Diagnostic x-ray digital imaging system workstation
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution

  • 00817100020209 ()


  • Diagnostic x-ray digital imaging system workstation
EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution

  • 00817100020193 ()


  • Diagnostic x-ray digital imaging system workstation
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-BAA-BXXXX
Not in Commercial Distribution

  • 00817655021270 ()


  • Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-DAACA
Not in Commercial Distribution

  • 00817655020617 ()


  • Patient health record information system
LessRay Small Monitor Set
Nuvasive, Inc.
LRSMLMONMKT
In Commercial Distribution

  • 00887517948328 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Large Monitor Set
Nuvasive, Inc.
LRLRGMONMKT
In Commercial Distribution

  • 00887517948311 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Isolation Transformer Set
Nuvasive, Inc.
LRISOMKT
In Commercial Distribution

  • 00887517948304 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Computer Set
Nuvasive, Inc.
LRCPUMKT
In Commercial Distribution

  • 00887517948199 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Table Array Set
Nuvasive, Inc.
LRCARTMKT
In Commercial Distribution

  • 00887517948182 ()


  • Diagnostic x-ray digital imaging system workstation
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