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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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Acetabular Shell, Polar Hole Sz 68
MODAL MANUFACTURING LLC
M-1210-0068
In Commercial Distribution

  • B035M121000681 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Acetabular Shell, Polar Hole Sz 66
MODAL MANUFACTURING LLC
M-1210-0066
In Commercial Distribution

  • B035M121000661 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Acetabular Shell, Polar Hole Sz 64
MODAL MANUFACTURING LLC
M-1210-0064
In Commercial Distribution

  • B035M121000641 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Acetabular Shell, Polar Hole Sz 62
MODAL MANUFACTURING LLC
M-1210-0062
In Commercial Distribution

  • B035M121000621 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Acetabular Shell, Polar Hole Sz 60
MODAL MANUFACTURING LLC
M-1210-0060
In Commercial Distribution

  • B035M121000601 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Acetabular Shell, Polar Hole Sz 58
MODAL MANUFACTURING LLC
M-1210-0058
In Commercial Distribution

  • B035M121000581 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Acetabular Shell, Polar Hole Sz 56
MODAL MANUFACTURING LLC
M-1210-0056
In Commercial Distribution

  • B035M121000561 ()


  • Metal-on-polyethylene total hip prosthesis
  • Ceramic-on-polyethylene total hip prosthesis
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7219
In Commercial Distribution

  • 07331791010071 ()

  • Length: 10 Millimeter
7219

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7221
In Commercial Distribution

  • 07331791010064 ()

  • Length: 12.5 Millimeter
7221

  • Tracheoesophageal speech valve, indwelling
Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.
Atos Medical AB
7224
In Commercial Distribution

  • 07331791010057 ()

  • Length: 15 Millimeter
7224

  • Tracheoesophageal speech valve, indwelling
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