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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Pharyngeal barrier
Xemax Surgical Products Inc
Pedo
In Commercial Distribution

  • D867CSP501 ()
  • D867CSP500 ()
CSP50

  • Non-woven gauze pad
Pharyngeal barrier
Xemax Surgical Products Inc
IV
In Commercial Distribution

  • D867CSIV1001 ()
  • D867CSIV1000 ()
CSIV100

  • Non-woven gauze pad
Pharyngeal barrier
Xemax Surgical Products Inc
III
In Commercial Distribution

  • D867CSIII001 ()
  • D867CSIII1000 ()
CSIII100

  • Non-woven gauze pad
Pharyngeal barrier
Xemax Surgical Products Inc
II
In Commercial Distribution

  • D867CSII001 ()
  • D867CSII1000 ()
CSII100

  • Non-woven gauze pad
YOUTH HC CLOSE PADS & PULL TAB 7-11 YEARS OLD
Ortho-Tain, Inc
HABIT CORRECTOR
In Commercial Distribution

  • D866HCCY40BPT0 ()
HC

  • Orthodontic retainer
YOUTH HC CLOSE WITH PADS 6-12 YEARS OLD
Ortho-Tain, Inc
HABIT CORRECTOR
In Commercial Distribution

  • D866HCCY40BP0 ()
HC

  • Orthodontic retainer
TODDLER HABIT CORRECTOR CLOSE REV.A 2-4 YEARS OLD ( NO PADS, WITH TAB)
Ortho-Tain, Inc
HABIT CORRECTOR
In Commercial Distribution

  • D866HCCT40AT0 ()
HC

  • Orthodontic retainer
SLENDERIZED KIDS+ HC W/PADS
Ortho-Tain, Inc
HABIT CORRECTOR
In Commercial Distribution

  • D866HCCSK40AP0 ()
HC

  • Orthodontic retainer
SLENDERIZED ADULT HABIT CORRECTOR W/PADS
Ortho-Tain, Inc
HABIT CORRECTOR
In Commercial Distribution

  • D866HCCSA40BP0 ()
HC

  • Orthodontic retainer
PEDO/KIDS HC PADS & PULL TAB 4-6 YEARS OLD
Ortho-Tain, Inc
HABIT CORRECTOR
In Commercial Distribution

  • D866HCCP40BPT0 ()
HC

  • Orthodontic retainer
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