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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
Biomet Orthopedics, LLC
31-301305
In Commercial Distribution

  • 00887868476433 ()

  • 60 mm Size E
31-301305

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-301105
In Commercial Distribution

  • 00887868476235 ()

  • Size E 60 mm
31-301105

  • Orthopaedic broach
No Description
Biomet Orthopedics, LLC
31-311355
In Commercial Distribution

  • 00887868478628 ()

  • Size E / 80 mm /
31-311355

  • Femoral stem prosthesis trial
No Description
Biomet Orthopedics, LLC
31-311345
In Commercial Distribution

  • 00887868478574 ()

  • Size E / 80 mm /
31-311345

  • Femoral stem prosthesis trial
LFIA kit for detection of IgE level in tear fluid.
Axim Biotechnologies, Inc.
CP0001
In Commercial Distribution

  • 00860009215139 ()
CP0001

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testing
Multi-unit scanbody
MEDENTiKA GmbH
E 8513
In Commercial Distribution

  • EMKAE85139 ()
  • 04251574849908 ()

  • NobelReplace Implant System of NobelBiocare
E 8513

  • Dental implant abutment analog, intraoral-scanning, single-use
Multi-unit scanbody
MEDENTiKA GmbH
E 8500
In Commercial Distribution

  • EMKAE85009 ()
  • 04251574849892 ()

  • NobelReplace Implant System of NobelBiocare
E 8500

  • Dental implant abutment analog, intraoral-scanning, single-use
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
1
In Commercial Distribution

  • EIBA120131E1 ()
  • EIBA120131E0 ()
120-131 E

  • Diagnostic x-ray system quality assurance device
Garth Nasal Mop
EXMOOR PLASTICS LIMITED
E.302
In Commercial Distribution

  • 05060180251932 ()
  • 05060180252083 ()
E.302

  • Cotton bud
Clinical type Combo IF+EMS
GEMORE TECHNOLOGY CO., LTD.
GM392IF/E
In Commercial Distribution

  • 24712832961281 ()
  • 04712832961287 ()
GM392IF/E

  • Analgesic transcutaneous electrical nerve stimulation system
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