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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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Surgimap® - 00859699006059

The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software

Surgimap® - 00859699006042

The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution

  • 00859699006042 ()


  • Radiological PACS software
  • Patient health record information system

QuantorView - 08809466041112

QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration.
Digiray Corp.
1.2.1.466
In Commercial Distribution

  • 08809466041112 ()


  • Radiological PACS software

EVA System - 17290016976028

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
EVA 3 Plus/EVA 3.1
In Commercial Distribution

  • 17290016976547 ()
  • 17290016976028 ()
  • 17290016976523 ()
  • 17290016976516 ()
  • 17290016976509 ()


  • Colposcope

EVA System - 17290016976011

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
3.0
In Commercial Distribution

  • 17290016976011 ()


  • Colposcope

EVA System - 17290016976004

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution

  • 17290016976004 ()


  • Colposcope

PDT, Inc. - 00813677024978

Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6 Discoid-Cleoid Carver (R284) Hollenback 1/2-3 Carver (R286) G2 Thin Composite (R287) G3 Thin Composite (R333) 27-29 Burnisher (R336) Calcium Hydroxide Placer (R347) 0-1 Blacks Plugger (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T356) Amalgam Well (T800) Iris Curved Scissors (11.5cm)
PDT, INC.
R937 PDT Total Restorative Kit
In Commercial Distribution

  • 00813677024978 ()
R937

  • Instrument tray, reusable
  • Dental mirror, reusable
  • Dental irrigation/aspiration syringe
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental restoration carver, resin
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental restoration carver, amalgam, reusable
  • Manual dental burnisher, reusable
  • Dental amalgam condenser, reusable
  • Dental amalgam well
  • Gingival retraction cord packing tool
  • Dental spatula, reusable
  • Dental excavator, reusable
  • Suture scissors

LifeTrak - B105LIFETRAK0

LifeTrak 2012 is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2012
In Commercial Distribution

  • B105LIFETRAK0 ()


  • Blood bank information system application software

WellSky Blood Centers - B105BLOODCENTERS2023

Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2023
In Commercial Distribution

  • B105BLOODCENTERS2023 ()


  • Blood bank information system application software

WellSky Blood Centers - B105BLOODCENTERS2019

Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2019
In Commercial Distribution

  • B105BLOODCENTERS2019 ()


  • Blood bank information system application software
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