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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
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45325-75100
In Commercial Distribution

  • B467ACP453257510016 ()
  • B467ACP4532575100 ()
ACP11

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75200
In Commercial Distribution

  • B467ACP452257520025 ()
  • B467ACP4522575200 ()
ACP12

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45125-75100
In Commercial Distribution

  • B467ACP451257510016 ()
  • B467ACP4512575100 ()
  • B467ACP451257510025 ()
ACP6/7

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36235-10200
In Commercial Distribution

  • B467ACP362351020025 ()
  • B467ACP3623510200 ()
  • B467ACP362351020033 ()
ACP4

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36225-10200
In Commercial Distribution

  • B467ACP362251020025 ()
  • B467ACP3622510200 ()
ACP3

  • Haemodialysis concentrate
Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
36220-10200
In Commercial Distribution

  • B467ACP362201020025 ()
  • B467ACP3622010200 ()
ACP2

  • Haemodialysis concentrate
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