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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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A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3106
In Commercial Distribution

  • M84931060 ()
3106

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3104
In Commercial Distribution

  • M84931040 ()
3104

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3102
In Commercial Distribution

  • M84931020 ()
3102

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Introduction Kit
Not in Commercial Distribution

  • D040200119303 ()
20011930

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Primer-15ml
Not in Commercial Distribution

  • D040200118701 ()

  • 15 ml
20011870

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Silicone Tube 12 oz.
Not in Commercial Distribution

  • D040200118602 ()

  • 12 oz.
20011860

  • Denture reliner, soft, professional
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
WHIP-MIX CORPORATION
Silicone Tube 4 oz.
Not in Commercial Distribution

  • D040200118501 ()

  • 4 oz.
20011850

  • Denture reliner, soft, professional
Crown Lok™ Blue is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok is a self-curing two minute working time fluoride releasing cement. This is 6gm Screw Blue Paste A Syringe
RELIANCE ORTHODONTIC PRODUCTS INC
CLSAB
In Commercial Distribution

  • D798CLSAB0 ()
CLSAB

  • Dental prosthesis veneer resin
The trial plate is used to choose the appropriate size of the final implant and to define its correct position. This model has 5 holes, is for the left side and is dedicated to the PTCG plate.
NEWDEAL
FPTCGND
In Commercial Distribution

  • M248FPTCGND1 ()
  • 10381780051817 ()

  • 43.0mm width; 83.5mm length; 2mm thickness; 27°, 47° bending angles


  • Surgical implant template, reusable
The trial plate is used to choose the appropriate size of the final implant and to define its correct position. This model has 5 holes, is for the right side and is dedicated to the PTCD plate.
NEWDEAL
FPTCDND
In Commercial Distribution

  • M248FPTCDND1 ()
  • 10381780051800 ()

  • 43.0mm width; 83.5mm length; 2mm thickness; 27°, 47° bending angles


  • Surgical implant template, reusable
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