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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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Flex-Ez Over the Wire Balloon Dilator - M84932060

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.
3206
In Commercial Distribution

  • M84932060 ()
3206

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Flex-Ez Over the Wire Balloon Dilator - M84932040

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.
3204
In Commercial Distribution

  • M84932040 ()
3204

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Flex-Ez Over the Wire Balloon Dilator - M84932020

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.
3202
In Commercial Distribution

  • M84932020 ()
3202

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Biliary Over the Wire Balloon Dilator - M84931840

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.
3184
In Commercial Distribution

  • M84931840 ()
3184

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Biliary Over the Wire Balloon Dilator - M84931820

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.
3182
In Commercial Distribution

  • M84931820 ()
3182

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Biliary Over the Wire Balloon Dilator - M84931800

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.
3180
In Commercial Distribution

  • M84931800 ()
3180

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Flex-Ez Over the Wire Balloon Dilator - M84931580

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.
3158
In Commercial Distribution

  • M84931580 ()
3158

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Flex-Ez Over the Wire Balloon Dilator - M84931560

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.
3156
In Commercial Distribution

  • M84931560 ()
3156

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Flex-Ez Over the Wire Balloon Dilator - M84931520

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.
3152
In Commercial Distribution

  • M84931520 ()
3152

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Flex-Ez Over the Wire Balloon Dilator - M84931060

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
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