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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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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
No Description
ACCUTOME, INC.
2.06.02-U
In Commercial Distribution

  • 00897826002147 ()


  • Ophthalmic ultrasound imaging system
No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738820 ()
019.2033

  • Dental milling system, CAD/CAM, chairside
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738813 ()
019.2032

  • Dental milling system, CAD/CAM, laboratory
Cranial Guidance Enable
Stryker Leibinger GmbH & Co. KG
6000-670-300
In Commercial Distribution

  • 07613327538410 ()
6000-670-300

  • Electromagnetic/optical surgical navigation device tracking system
Cranial Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81042
In Commercial Distribution

  • 07613327538328 ()
81-81042

  • Electromagnetic/optical surgical navigation device tracking system
No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit
Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0010
Not in Commercial Distribution

  • 00815686021085 ()
SFT-0010

  • Virtual bronchoscopic navigation PACS software
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