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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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Modus Nav Software - 00670082000627

No Description
Synaptive Medical Inc
2.2
In Commercial Distribution

  • 00670082000627 ()
SYN-0867

  • Neurological stereotactic surgery system

Modus Nav Software - 00670082000504

No Description
Synaptive Medical Inc
2.1
In Commercial Distribution

  • 00670082000504 ()
SYN-0867

  • Neurological stereotactic surgery system

BrightMatter Guide Software - 00670082000375

No Description
Synaptive Medical Inc
1.5
In Commercial Distribution

  • 00670082000375 ()
SYN-0027

  • Neurological stereotactic surgery system

BrightMatter Guide Software - 00670082000191

No Description
Synaptive Medical Inc
1.4
In Commercial Distribution

  • 00670082000191 ()
SYN-0027

  • Neurological stereotactic surgery system

BrightMatter Guide Software - 00670082000078

No Description
Synaptive Medical Inc
1.3
In Commercial Distribution

  • 00670082000078 ()
SYN-0027

  • Neurological stereotactic surgery system

SureSmile Aligner Software - 00856379007085

No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007085 ()


  • CAD/CAM software

WalkAnalyst Software Kit - 00858184006130

Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution

  • 00858184006130 ()


  • Gait-enhancement electrical stimulation system, external

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

AMICUS Separator Software - 04086000101912

Software version for Amicus Separator
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 04086000101912 ()


  • Apheresis system

AMICUS Separator Software - 04086000101660

Software version for Amicus Separator.
Fresenius Kabi AG
5.12
In Commercial Distribution

  • 04086000101660 ()


  • Apheresis system
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