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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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Disposable Prophy Angles
Premium Plus International Limited
W3399-090RL
In Commercial Distribution

  • D838W3399090RL8 ()
  • D838W3399090RL2 ()
  • D838W3399090RL0 ()


  • Dental polishing cup, single-use
Disposable Prophy Angles
Premium Plus International Limited
W3399-090RB
In Commercial Distribution

  • D838W3399090RB8 ()
  • D838W3399090RB2 ()
  • D838W3399090RB0 ()


  • Dental polishing cup, single-use
Disposable Prophy Angles
Premium Plus International Limited
W3399-090F
In Commercial Distribution

  • D838W3399090F8 ()
  • D838W3399090F2 ()
  • D838W3399090F0 ()


  • Dental polishing cup, single-use
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
Endodontic instrument for professionnal dental use only
MICRO MEGA
ASST EVO FLEX L31 Sterile
In Commercial Distribution

  • J015600402049 ()
  • J015600402041 ()
  • J015600402040 ()
60040204

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
ASST EVO FLEX L25 Sterile
In Commercial Distribution

  • J015600402039 ()
  • J015600402031 ()
  • J015600402030 ()
60040203

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
ASST EVO FLEX L21 Sterile
In Commercial Distribution

  • J015600402029 ()
  • J015600402021 ()
  • J015600402020 ()
60040202

  • Rotary/reciprocating endodontic file/rasp, single-use
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