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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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PENTAX Medical - 04961333248933

PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia)
HOYA CORPORATION
EG36-J10UR
Not in Commercial Distribution

  • 04961333248902 ()
  • 04961333248933 ()


  • Flexible ultrasound gastroduodenoscope

PENTAX Medical - 04961333248711

PENTAX Medical Video Colonoscope EC34-i10c Series (Made in Malaysia)
HOYA CORPORATION
EC34-i10cL
Not in Commercial Distribution

  • 04961333248681 ()
  • 04961333248711 ()


  • Flexible video colonoscope, reusable

PENTAX - 04961333248315

PENTAX VIDEO UPPER G.I.SCOPE EG29-i10 (Made in Malaysia)
HOYA CORPORATION
EG29-i10
Not in Commercial Distribution

  • 04961333248292 ()
  • 04961333248315 ()


  • Flexible video gastroscope, reusable

PENTAX - 04961333248209

PENTAX VIDEO COLONOSCOPE EC38-i10 SERIES (Made in Malaysia)
HOYA CORPORATION
EC38-i10L
Not in Commercial Distribution

  • 04961333248186 ()
  • 04961333248209 ()


  • Flexible video colonoscope, reusable

PENTAX - 04961333248179

VIDEO UPPER G.I.SCOPE EG-2990i (Made in Malaysia)
HOYA CORPORATION
EG-2990i
Not in Commercial Distribution

  • 04961333248155 ()
  • 04961333248179 ()


  • Flexible video gastroscope, reusable

PENTAX - 04961333248148

PENTAX VIDEO COLONOSCOPE EC-3890i SERIES (Made in Malaysia)
HOYA CORPORATION
EC-3890Li
Not in Commercial Distribution

  • 04961333248124 ()
  • 04961333248148 ()


  • Flexible video colonoscope, reusable

PENTAX Medical - 04961333248070

PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU)
HOYA CORPORATION
VNL15-J10
In Commercial Distribution

  • 04961333221417 ()
  • 04961333248070 ()


  • Flexible video otorhinolaryngoscope, reusable

PENTAX Medical - 04961333245888

PENTAX Medical Video Upper GI Scope EG34-i10
HOYA CORPORATION
EG34-i10
In Commercial Distribution

  • 04961333233991 ()
  • 04961333245888 ()


  • Flexible video gastroscope, reusable

N/A - 04961333244270

ADAPTER FOR 70K W/O FWJ
PENTAX OF AMERICA, INC.
QPC1713
In Commercial Distribution

  • 04961333244270 ()


  • Luminal device flushing tubing set, reusable

N/A - 04961333244188

WATER BOTTLE, REUSABLE
PENTAX OF AMERICA, INC.
OS-H5
In Commercial Distribution

  • 04961333244188 ()


  • Endoscopic irrigation/distension bottle
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