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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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AngioDynamics - H965457500

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45750
In Commercial Distribution

  • H965457501 ()
  • H965457500 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.42 Millimeter
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable

AngioDynamics - H965457480

Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45748
In Commercial Distribution

  • H965457481 ()
  • H965457480 ()

  • Catheter Gauge: 4 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.42 Millimeter
  • Length: 10 Centimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

Navilyst - H965457470

Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
NAVILYST MEDICAL, INC.
45747
In Commercial Distribution

  • H965457471 ()
  • H965457470 ()

  • Length: 145 Centimeter
  • Outer Diameter: 0.018 Inch


  • Cardiac/peripheral vascular guidewire, single-use

Navilyst - H965457460

Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
NAVILYST MEDICAL, INC.
45746
In Commercial Distribution

  • H965457461 ()
  • H965457460 ()

  • Length: 70 Centimeter
  • Outer Diameter: 0.018 Inch


  • Cardiac/peripheral vascular guidewire, single-use

TissuGlu Surgical Adhesive - M690TG100US0

TissuGlu Surgical Adhesive
COHERA MEDICAL, INC.
TG100US
In Commercial Distribution

  • M690TG100US0 ()
  • M690TG100US3 ()
TG100US

  • Surgical internal adhesive/sealant, synthetic polymer

PALACOS - J014002112140011

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 - J014001119140011

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 - J014001118140011

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 - J014001113140011

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

MicroMega One Curve mini - J015600300351

Endodontic instrument for professionnal dental use only
MICRO MEGA
L31 Assorted Sterile
In Commercial Distribution

  • J015600300359 ()
  • J015600300351 ()
  • J015600300350 ()
60030035

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