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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Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45777
In Commercial Distribution

  • H965457771 ()
  • H965457770 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45776
In Commercial Distribution

  • H965457761 ()
  • H965457760 ()

  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45775
In Commercial Distribution

  • H965457751 ()
  • H965457750 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45774
In Commercial Distribution

  • H965457741 ()
  • H965457740 ()

  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45773
In Commercial Distribution

  • H965457731 ()
  • H965457730 ()

  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45772
In Commercial Distribution

  • H965457721 ()
  • H965457720 ()

  • Outer Diameter: 1.73 Millimeter
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45771
In Commercial Distribution

  • H965457711 ()
  • H965457710 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45770
In Commercial Distribution

  • H965457701 ()
  • H965457700 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45769
In Commercial Distribution

  • H965457691 ()
  • H965457690 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45768
In Commercial Distribution

  • H965457681 ()
  • H965457680 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45767
In Commercial Distribution

  • H965457671 ()
  • H965457670 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45766
In Commercial Distribution

  • H965457661 ()
  • H965457660 ()

  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45765
In Commercial Distribution

  • H965457651 ()
  • H965457650 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.73 Millimeter


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45764
In Commercial Distribution

  • H965457641 ()
  • H965457640 ()

  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45763
In Commercial Distribution

  • H965457631 ()
  • H965457630 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45762
In Commercial Distribution

  • H965457621 ()
  • H965457620 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45761
In Commercial Distribution

  • H965457611 ()
  • H965457610 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45760
In Commercial Distribution

  • H965457601 ()
  • H965457600 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45759
In Commercial Distribution

  • H965457591 ()
  • H965457590 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45758
In Commercial Distribution

  • H965457581 ()
  • H965457580 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45757
In Commercial Distribution

  • H965457571 ()
  • H965457570 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45756
In Commercial Distribution

  • H965457561 ()
  • H965457560 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45755
In Commercial Distribution

  • H965457551 ()
  • H965457550 ()

  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 5 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45754
In Commercial Distribution

  • H965457541 ()
  • H965457540 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 10 Centimeter
  • Outer Diameter: 1.73 Millimeter
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45753
In Commercial Distribution

  • H965457531 ()
  • H965457530 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45752
In Commercial Distribution

  • H965457521 ()
  • H965457520 ()

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


  • Vascular catheter introduction set, nonimplantable
Mini Stick MAX Coaxial Microintroducer Kit
NAVILYST MEDICAL, INC.
45751
In Commercial Distribution

  • H965457511 ()
  • H965457510 ()

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


  • Vascular catheter introduction set, nonimplantable
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
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
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
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
COHERA MEDICAL, INC.
TG100US
In Commercial Distribution

  • M690TG100US0 ()
  • M690TG100US3 ()
TG100US

  • Surgical internal adhesive/sealant, synthetic polymer
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
L31 Assorted Sterile
In Commercial Distribution

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

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

  • J015600300349 ()
  • J015600300341 ()
  • J015600300340 ()
60030034

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

  • J015600300339 ()
  • J015600300331 ()
  • J015600300330 ()
60030033

  • Rotary/reciprocating endodontic file/rasp, single-use
Endodontic instrument for professionnal dental use only
MICRO MEGA
n45 4% L25 Sterile
In Commercial Distribution

  • J015600300329 ()
  • J015600300320 ()
  • J015600300321 ()
60030032

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