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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Dual Laminate 120mm Round 12Ea
Keystone Industries
9603580R2
In Commercial Distribution

  • H6689603580R20 ()
  • H6689603580R21 ()
9603580R2

  • Dental appliance fabrication material, thermoplastic
Dual Laminate 125mm Round 12Ea
Keystone Industries
9603580R1
In Commercial Distribution

  • H6689603580R10 ()
  • H6689603580R11 ()
9603580R1

  • Dental appliance fabrication material, thermoplastic
Dual Laminates 12Ea
Keystone Industries
9603580
In Commercial Distribution

  • H66896035800 ()
  • H66896035801 ()
9603580

  • Dental appliance fabrication material, thermoplastic
Nightguard Laminate 0.120 (3mm) 300Ea
Keystone Industries
9602555
In Commercial Distribution

  • H66896025550 ()
  • H66896025551 ()
9602555

  • Dental appliance fabrication material, thermoplastic
Nightguard Laminate 0.120 (3mm) 12 Ea
Keystone Industries
9602550
In Commercial Distribution

  • H66896025500 ()
  • H66896025501 ()
9602550

  • Dental appliance fabrication material, thermoplastic
Content: 1 piece Height: 25 mm. Used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
ZIRKONZAHN SRL
TMIC1825
In Commercial Distribution

  • D800TMIC1825 ()


  • Dental bridge, polymer
Content: 1 piece Height: 20 mm. Used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
ZIRKONZAHN SRL
TMIC1820
In Commercial Distribution

  • D800TMIC1820 ()


  • Dental bridge, polymer
Content: 1 piece Height: 16 mm. Used for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.
ZIRKONZAHN SRL
TMIC1816
In Commercial Distribution

  • D800TMIC1816 ()


  • Dental bridge, polymer
Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Capture-R Ready-Screen (3) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods.
IMMUCOR, INC.
0066901
In Commercial Distribution

  • 10888234001539 ()
0066901

  • Solid-phase red blood cell adherence antibody/antigen IVD
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