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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 - 04961333253920

Balloon For EG-3270UK OE-A56
HOYA CORPORATION
OE-A56
In Commercial Distribution

  • 84961333253926 ()
  • 04961333253920 ()


  • Ultrasound endoscope balloon, synthetic polymer

PENTAX - 04961333253913

PENTAX Balloon OE-A52
HOYA CORPORATION
OE-A52
In Commercial Distribution

  • 84961333253919 ()
  • 04961333253913 ()


  • Ultrasound endoscope balloon, synthetic polymer

PENTAX - 04961333253906

Balloon OE-A51
HOYA CORPORATION
OE-A51
In Commercial Distribution

  • 84961333253902 ()
  • 04961333253906 ()


  • Ultrasound endoscope balloon, synthetic polymer

N/A - 04961333245291

STANDALONE IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68407
In Commercial Distribution

  • 04961333245291 ()


  • Radiology information system

N/A - 04961333242856

PROFILE SINGLE USE ENDOSCOPE CLEANING BR
PENTAX OF AMERICA, INC.
CS-C11A
In Commercial Distribution

  • 04961333242856 ()


  • Surgical instrument/endoscope cleaning utensil, single-use

N/A - 04961333242818

PROFILE SINGLE USE ENDOSCOPE CLEANING BR
PENTAX OF AMERICA, INC.
CS-4010A
In Commercial Distribution

  • 04961333242818 ()


  • Surgical instrument/endoscope cleaning utensil, single-use

N/A - 04961333242184

MEDICAP USB 300
PENTAX OF AMERICA, INC.
9139HD
In Commercial Distribution

  • 04961333242184 ()


  • Digital storage media

N/A - 04961333242009

MIC, LAPEL ASSY REV D
PENTAX OF AMERICA, INC.
7175-6000
In Commercial Distribution

  • 04961333242009 ()


  • Voice amplification system

N/A - 04961333241835

KEYBOARD, SUPER MINI USB
PENTAX OF AMERICA, INC.
1111-1871
In Commercial Distribution

  • 04961333241835 ()


  • Digital storage media

N/A - 04961333241392

ISOLATION TRANSFORMER 1200V 10A 4 OUTLETS
PENTAX OF AMERICA, INC.
90075
In Commercial Distribution

  • 04961333241392 ()


  • Constant-voltage transformer
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