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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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Silicone Sheeting Non-Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.508mm
In Commercial Distribution

  • M72423700202 ()
  • M72423700201 ()
23-700-20

  • Silicone-sheet tissue reconstructive material, non-sterile
Silicone Sheeting Non-Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.381mm
In Commercial Distribution

  • M72423700152 ()
  • M72423700151 ()
23-700-15

  • Silicone-sheet tissue reconstructive material, non-sterile
Silicone Sheeting Non-Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.254mm
In Commercial Distribution

  • M72423700102 ()
  • M72423700101 ()
23-700-10

  • Silicone-sheet tissue reconstructive material, non-sterile
Silicone Sheeting Non-Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.178mm
In Commercial Distribution

  • M72423700072 ()
  • M72423700071 ()
23-700-07

  • Silicone-sheet tissue reconstructive material, non-sterile
Silicone Sheeting Non-Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.127mm
In Commercial Distribution

  • M72423700051 ()
  • M72423700052 ()
23-700-05

  • Silicone-sheet tissue reconstructive material, non-sterile
PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
R
Not in Commercial Distribution

  • J014002112140011 ()
  • J014001112140012 ()
00-1112-140-01

  • Orthopaedic cement, non-antimicrobial
PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin. PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
LV+G
Not in Commercial Distribution

  • J014001119140011 ()
  • J014001119140012 ()
00-1119-140-01

  • Orthopaedic cement, non-antimicrobial
PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS® LV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field it has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
LV
Not in Commercial Distribution

  • J014001118140011 ()
  • J014001118140012 ()
00-1118-140-01

  • Orthopaedic cement, non-antimicrobial
PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
Heraeus Medical GmbH
R+G
Not in Commercial Distribution

  • J014001113140011 ()
  • J014001113140012 ()
00-1113-140-01

  • Orthopaedic cement, non-antimicrobial
NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
60140149
In Commercial Distribution

  • H965601401490 ()
  • H965601401491 ()


  • Angiography kit
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