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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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No Description
SCIMEDX CORPORATION
6005
In Commercial Distribution

  • 00813545020682 ()
6005

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
No Description
Neotech Products LLC
00812594012396
In Commercial Distribution

  • 00812594012396 ()
N9105CO-B

  • Tracheostomy tube neck holder, reusable
No Description
Neotech Products LLC
00812594012327
In Commercial Distribution

  • 00812594012327 ()
N9105BL-B

  • Tracheostomy tube neck holder, reusable
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB5705
In Commercial Distribution

  • 00813909013428 ()

  • 16x5x22 mm
NB5705

  • Bone matrix implant, synthetic, non-antimicrobial
Implants for orthopedic bone fixation, compatible with 2.7mm/3.5mm/4.0mm Screws.
FLOWER ORTHOPEDICS CORPORATION
DLF 505
In Commercial Distribution

  • 00840118110778 ()

  • Height: 1.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
54319-61
In Commercial Distribution

  • 10810929045146 ()
  • 00810929045149 ()


  • Medical device cleaning agent
Actuated Holder
MIZUHO AMERICA, INC.
07-863-05
In Commercial Distribution

  • 00810009463511 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
OnGuard2 Syringe Adaptor, 5 Units is part of the Chemfort CSTD system. The device distal end is intended to connect to Chemfort port (e.g., Vial Adaptor) The device Proximal end is intended to connect to luer syringe
SIMPLIVIA HEALTHCARE LTD
412188
In Commercial Distribution

  • 37290115921886 ()
  • 27290115921889 ()
  • 17290115921882 ()


  • Medication transfer set
Freevent XtraCare and Freevent XtraCare Mini are single use Heat and Moisture Exchangers with electrostatic filters (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma
Atos Medical AB
7789
In Commercial Distribution

  • 07331791016578 ()
  • 07331791008979 ()
7789

  • Tracheostoma protective filter
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