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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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N/A - 00885556607480

SERVICE REP SOFTWARE V2.4
Smith & Nephew, Inc.
7205006S
Not in Commercial Distribution

  • 00885556607480 ()
7205006S

  • Electrical-only medical device connection cable, reusable

CareLink™ Software - 00763000242787

PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software

Eonis Analysis software - 06438147373901

The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution

  • 06438147373901 ()
5020-1000

  • Human genomic analysis interpretive software IVD

SureSmile Aligner Software - 00856379007085

No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007085 ()


  • CAD/CAM software

Virtual Eye Software - 00860010709795

No Description
Virtual Vision Health
3.2.0
In Commercial Distribution

  • 00860010709795 ()
VV-021

  • Perimeter, automatic

Virtual Eye Software - 00860010709788

No Description
Virtual Vision Health
3.1.0
In Commercial Distribution

  • 00860010709788 ()


  • Perimeter, automatic

Virtual Eye Software - 00860010709757

No Description
Virtual Vision Health
3.0.0
In Commercial Distribution

  • 00860010709757 ()


  • Perimeter, automatic

Virtual Eye Software - 00860010709740

No Description
Virtual Vision Health
2.7.0
In Commercial Distribution

  • 00860010709740 ()


  • Perimeter, automatic

Virtual Eye Software - 00860010709733

No Description
Virtual Vision Health
2.6.0
In Commercial Distribution

  • 00860010709733 ()


  • Perimeter, automatic

D-Scope Server Software - 00860009377615

D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR (HL7) and PACS/VNA (DICOM).
D-Scope Systems
6
In Commercial Distribution

  • 00860009377615 ()


  • Endoscopic video image processing unit
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