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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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FONA STELLARIS - D7641000054111

FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005411
In Commercial Distribution

  • D7641000054111 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000054101

FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005410
In Commercial Distribution

  • D7641000054101 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053931

FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005393
In Commercial Distribution

  • D7641000053931 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053921

FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005392
In Commercial Distribution

  • D7641000053921 ()


  • Dental digital imaging sensor, intraoral

FONA STELLARIS - D7641000053911

FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005391
In Commercial Distribution

  • D7641000053911 ()


  • Dental digital imaging sensor, intraoral

OrthoScan Pulse Mini C-arm - B22510000004FD0

Image-intensified fluoroscopic x-ray system, mobile
Ziehm-Orthoscan, Inc.
1000-0004-FD
In Commercial Distribution

  • B22510000004FD0 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Lyra - 30014613311034

Lyra RSV+HMPV Assay
DIAGNOSTIC HYBRIDS, INC.
M103
In Commercial Distribution

  • 30014613311034 ()
M103

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ Flu A/B & RSV Direct Gen II - 20816101026962

No Description
DIASORIN MOLECULAR LLC
MOL2655
In Commercial Distribution

  • 20816101026962 ()
MOL2655

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Panther Fusion® - 15420045509313

Panther Fusion® Flu A/B/RSV Controls Kit.
Hologic, Inc.
FLU A B RSV CTRLS, PANTHER FUSION, IVD
In Commercial Distribution

  • 15420045509313 ()
PRD-04336

  • Multiple-genus respiratory virus nucleic acid IVD, control

Panther Fusion® - 15420045509283

The Panther Fusion® Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
Hologic, Inc.
FLU A B RSV, PANTHER FUSION, 96T, IVD
In Commercial Distribution

  • 15420045509283 ()
PRD-04328

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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