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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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not applicable - 00195278711229

UDI Software Pristina
GE MEDICAL SYSTEMS
PRISTINA 2.8.3
In Commercial Distribution

  • 00195278711229 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

PULSE - 00195377065544

PULSE Software, v4.0.0-bln.eu
Nuvasive, Inc.
1802497
In Commercial Distribution

  • 00195377065544 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065537

PULSE Software, v4.0.0-bln.us
Nuvasive, Inc.
1802495
In Commercial Distribution

  • 00195377065537 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065520

PULSE Software, v4.0.0-bl.eu
Nuvasive, Inc.
1802493
In Commercial Distribution

  • 00195377065520 ()


  • Orthopaedic stereotactic surgery system

PULSE - 00195377065513

PULSE Software, v4.0.0-bl.us
Nuvasive, Inc.
1802491
In Commercial Distribution

  • 00195377065513 ()


  • Orthopaedic stereotactic surgery system

Merge PACS - 00842000100607

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.1.0
In Commercial Distribution

  • 00842000100607 ()


  • Radiological PACS software

Merge Cardio - 00842000100591

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
10.1
In Commercial Distribution

  • 00842000100591 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100584

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.1.4
Not in Commercial Distribution

  • 00842000100584 ()


  • Radiological PACS software

Merge OrthoPACS - 00842000100577

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.0.2
In Commercial Distribution

  • 00842000100577 ()


  • Radiological PACS software

Merge PACS - 00842000100560

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
7.0.2
In Commercial Distribution

  • 00842000100560 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100553

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.1.1 Patch 1
Not in Commercial Distribution

  • 00842000100553 ()


  • Radiological PACS software

Merge PACS - 00842000100508

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6.3.2
In Commercial Distribution

  • 00842000100508 ()


  • Radiological PACS software

Merge Cardio - 00842000100416

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.0
In Commercial Distribution

  • 00842000100416 ()


  • Radiology picture archiving and communication system workstation

Merge OrthoPACS - 00842000100348

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6.3.2
In Commercial Distribution

  • 00842000100348 ()


  • Radiological PACS software

Merge Unity PACS - 00842000100331

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
11.2
In Commercial Distribution

  • 00842000100331 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100317

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.3
Not in Commercial Distribution

  • 00842000100317 ()


  • Radiological PACS software

eFilm Lite - 00842000100294

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.2
Not in Commercial Distribution

  • 00842000100294 ()


  • Radiological PACS software

eFilm Workstation - 00842000100287

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
4.2
Not in Commercial Distribution

  • 00842000100287 ()


  • Radiological PACS software

Merge iConnect Access - 00842000100126

Standalone software application.
MERGE HEALTHCARE SOLUTIONS INC.
6.3
In Commercial Distribution

  • 00842000100126 ()


  • Radiological PACS software

Merge Eye Care PACS - 00842000100096

Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
5.2
Not in Commercial Distribution

  • 00842000100096 ()


  • Radiological PACS software
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