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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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A soft-adherent lipido-colloid foam dressing consisting of a coating on a polyurethane pad with a micro-adherent lipido-colloid matrix.
URGO MEDICAL NORTH AMERICA, LLC
509384
In Commercial Distribution

  • 10190769093843 ()
  • 00190769093846 ()

  • 5 X 7.5 inch Heel
509384

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Basic Set for AuDX PRO branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX PRO A/N100098-AUP - Headphone HDA300 A/N100630 - Probe EP-DP PATH long A/N100028-US - Gooseneck microphone A/N 100779 - FW TEOAE A/N100109 - FW DPOAE A/N100110 - FW FMDPOAE A/N100536 - FW DPHiRES A/N 100537 - FW PTA Class 3 A/N100114 - FW High frequency A/N100454 - FW Magic A/N100112 - Speech material Spondees child A/N100463-UT08 - Speech material Spondees adult A/N100463-UT10 - Speech material NU-6 A/N100463-UT11 - Speech material CID W-22 A/N100463-UT12 - Speech material PBK-50 A/N100463-UT13 - Speech material Maryland CNC A/N100463-UT15 - FW Live A/N100825 - FW Mira PC- Software A/N100116 - FW Labelprinter A/N100414 - Accessory box combo A/N100261 - Power Supply Sentiero US A/N100083-US - User Manual A/N100904-EN-BL
PATH medical GmbH
100250-BLP1
Not in Commercial Distribution

  • 04260223143342 ()


  • Evoked-potential audiometer
Mumps Control Slide
EMD Millipore Corporation
5029
Not in Commercial Distribution

  • 04061839704138 ()
5029

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Mumps Control Slides
EMD Millipore Corporation
5029-5
Not in Commercial Distribution

  • 04053252364068 ()
5029-5

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Mumps IFA Kit
EMD Millipore Corporation
3140
Not in Commercial Distribution

  • 04053252329746 ()
3140

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Mumps Monoclonal Antibody
EMD Millipore Corporation
5028
Not in Commercial Distribution

  • 04053252282713 ()
5028

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The Revogene Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.
Meridian Bioscience Canada Inc
410400
Not in Commercial Distribution

  • 00628055344179 ()
410400

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.
GenePoc Inc
133674
Not in Commercial Distribution

  • 00628055344087 ()
133674

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
JBAIDS IVD Influenza A & B Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0137
Not in Commercial Distribution

  • 00851458005068 ()
JRPD-ASY-0137

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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