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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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Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TC2014
In Commercial Distribution

  • 10381780114819 ()
  • M268TC20141 ()

  • 14 mm L x 2.10 mm dia; 5.5 mm thread
TC2014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TC2012
In Commercial Distribution

  • 10381780114802 ()
  • M268TC20121 ()

  • 12 mm L x 2.10 mm dia; 4.5 mm thread
TC2012

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TC2010
In Commercial Distribution

  • 10381780114796 ()
  • M268TC20101 ()

  • 10 mm L x 2.10 mm dia; 4 mm thread
TC2010

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TC2008
In Commercial Distribution

  • 10381780114789 ()
  • M268TC20081 ()

  • 8 mm L x 2.10 mm dia; 3.5 mm thread
TC2008

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Ti6 Low Profile Bone Screw - TC-Series (Titanium Cannulated) is a cannulated, threaded bone screw used in the Integra® Ti6® Internal Fixation System
Ascension Orthopedics, Inc.
TC2006
In Commercial Distribution

  • 10381780114772 ()
  • M268TC20061 ()

  • 6 mm L x 2.10 mm dia; 3 mm thread
TC2006

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141501 ()
  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.
ZIEN MEDICAL TECHNOLOGIES, INC.
PWR-10
Not in Commercial Distribution

  • B090PWR101 ()
  • B090PWR100 ()
  • B090PWR102 ()


  • Angiographic syringe
The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-3-60) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
NORTH EAST SCIENTIFIC INC
CF7-3-60
In Commercial Distribution

  • B227RCF73600 ()

  • Length: 60 Centimeter
  • Catheter Gauge: 7 French
  • Heating element Length: 3 Centimeter
  • Heating Element Diameter: 0.225 Centimeter
  • Heating element Length: 3 Centimeter
R-CF7-3-60

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-60) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
NORTH EAST SCIENTIFIC INC
CF7-7-60
In Commercial Distribution

  • B227RCF77600 ()

  • Heating Element Length: 7 Centimeter
  • Heating Element Diameter: 0.225 Centimeter
  • Catheter Gauge: 7 French
  • Length: 60 Centimeter
R-CF7-7-60

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
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