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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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Tip, Switchable, Omni HP System, 0 degree
TRIMEDYNE, INC.
20474-HP
In Commercial Distribution

  • M47320474HP1 ()
  • M47320474HP0 ()
20474-HP

  • General/multiple surgical laser system beam guide, single-use
SwitchTip, Sidefire, 25cm
TRIMEDYNE, INC.
20462-HP
In Commercial Distribution

  • M47320462HP1 ()
  • M47320462HP0 ()
20462-HP

  • General/multiple surgical laser system beam guide, single-use
Mistral-Air Blanket, Cardiac Blanket Plus (sterile) - SYK
The Surgical Company International B.V.
MA2286-PM
In Commercial Distribution

  • ET37MA2286PM0 ()
  • ET37MA2286PM1 ()


  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Mistral-Air Blanket, Lower Surgical Access Plus (sterile) - SYK
The Surgical Company International B.V.
MA2285-PM
In Commercial Distribution

  • ET37MA2285PM0 ()
  • ET37MA2285PM1 ()


  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Mistral-Air Blanket, Surgical Access Plus (sterile) - SYK
The Surgical Company International B.V.
MA2280-PM
In Commercial Distribution

  • ET37MA2280PM0 ()
  • ET37MA2280PM1 ()


  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Light Handle - Provides a sterile cover over surgical lamp handle.
Supply Line International Medical, LLC
DLH01
In Commercial Distribution

  • G018DLH012 ()
  • G018DLH010 ()


  • Medical equipment handle cover, 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
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