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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ADPTR,ADJSTBL UNVRSL FOR ACTIVE CORDS FO
PENTAX OF AMERICA, INC.
84109
In Commercial Distribution

  • 04961333241217 ()


  • Electrical mains power cable
ENDOBRONCHIAL ULTRASOUND FLEX TBNA NEEDL
PENTAX OF AMERICA, INC.
82448
In Commercial Distribution

  • 04961333241200 ()


  • Flexible ultrasound bronchoscope
ENDOBRONCHIAL TBNA NEEDLE 22GA 4.0L 5PC
PENTAX OF AMERICA, INC.
82447
In Commercial Distribution

  • 04961333241194 ()
  • 14961333241191 ()

  • Needle Gauge: 22.0 Gauge
  • Total Volume: 4.0 Liter


  • Flexible ultrasound bronchoscope
DOUBLE GAS BOTTLE HOLDER FOR 80247
PENTAX OF AMERICA, INC.
80253
In Commercial Distribution

  • 04961333241149 ()


  • Endoscope transport trolley tray
CONNECTOR CLEANING J&J
PENTAX OF AMERICA, INC.
20366
In Commercial Distribution

  • 04961333240708 ()


  • Luminal device flushing tubing set, reusable
LENS ADAPTOR 20MM
PENTAX OF AMERICA, INC.
9703
In Commercial Distribution

  • 04961333240692 ()


  • Rigid optical nasopharyngoscope
LARYNGEAL STROBE
PENTAX OF AMERICA, INC.
9400
In Commercial Distribution

  • 04961333240685 ()


  • Laryngostroboscope
HD CAMERA (HD MOS)
PENTAX OF AMERICA, INC.
9215
In Commercial Distribution

  • 04961333240678 ()


  • Endoscope video camera
REMOVABLE HARD DRIVES - 9200D
PENTAX OF AMERICA, INC.
9204
In Commercial Distribution

  • 04961333240661 ()


  • Video cassette recorder
MEDICAP USB200 DIGITAL REC
PENTAX OF AMERICA, INC.
9139
In Commercial Distribution

  • 04961333240654 ()


  • Digital storage media
ADAPTOR FOR WELCH-ALLYN
PENTAX OF AMERICA, INC.
9125
In Commercial Distribution

  • 04961333240647 ()


  • Rigid optical nasopharyngoscope
MACHITA SCOPE ADAPTOR
PENTAX OF AMERICA, INC.
9124
In Commercial Distribution

  • 04961333240630 ()


  • Rigid optical nasopharyngoscope
WOLF RIGID SCOPE ADAPTOR
PENTAX OF AMERICA, INC.
9123
In Commercial Distribution

  • 04961333240623 ()


  • Rigid optical nasopharyngoscope
PENTAX ADAPTOR
PENTAX OF AMERICA, INC.
9122
In Commercial Distribution

  • 04961333240616 ()


  • Rigid optical nasopharyngoscope
ADAPTOR FOR STORZ
PENTAX OF AMERICA, INC.
9121
In Commercial Distribution

  • 04961333240609 ()


  • Rigid optical nasopharyngoscope
ADAPTOR FOR OLYMPUS
PENTAX OF AMERICA, INC.
9120
In Commercial Distribution

  • 04961333240593 ()


  • Rigid optical nasopharyngoscope
5197-804 ZOOM COUPLER, 19.5MM
PENTAX OF AMERICA, INC.
9118
In Commercial Distribution

  • 04961333240586 ()

  • Length: 19.5 Millimeter


  • Rigid optical nasopharyngoscope
LENS ADAPTOR - 45MM
PENTAX OF AMERICA, INC.
9117
In Commercial Distribution

  • 04961333240579 ()

  • Length: 45.0 Millimeter


  • Rigid optical nasopharyngoscope
LENS ADAPTOR FOR RIGID-35MM
PENTAX OF AMERICA, INC.
9116
In Commercial Distribution

  • 04961333240562 ()

  • Length: 35.0 Millimeter


  • Rigid optical nasopharyngoscope
RIDID ENDOSCOPE,STERRAD NX CO
PENTAX OF AMERICA, INC.
9109
In Commercial Distribution

  • 04961333240555 ()

  • Angle: 70.0 degree
  • Outer Diameter: 8.5 Millimeter


  • Rigid optical nasopharyngoscope
RIGID ENDOSCOPE 70 DEG. 6MM
PENTAX OF AMERICA, INC.
9108
In Commercial Distribution

  • 04961333240548 ()

  • Angle: 70.0 degree
  • Outer Diameter: 6.0 Millimeter


  • Rigid optical nasopharyngoscope
RIGID ENDOSCOPE 70 DEG. 10MM
PENTAX OF AMERICA, INC.
9106
In Commercial Distribution

  • 04961333240531 ()

  • Angle: 70.0 degree
  • Outer Diameter: 9.5 Millimeter


  • Rigid optical nasopharyngoscope
HANDLE FOR INSERT
PENTAX OF AMERICA, INC.
8862
In Commercial Distribution

  • 04961333240524 ()


  • Rigid optical nasopharyngoscope
ADAPTABLE TUBE, 70 DEG
PENTAX OF AMERICA, INC.
8861
In Commercial Distribution

  • 04961333240517 ()

  • Angle: 70.0 degree


  • Rigid optical nasopharyngoscope
PORTABLE SWALLOWING CART
PENTAX OF AMERICA, INC.
7273
In Commercial Distribution

  • 04961333240500 ()


  • Endoscope transport trolley
6450 CARRYING CASE
PENTAX OF AMERICA, INC.
6454
In Commercial Distribution

  • 04961333240487 ()


  • Medical capital equipment storage bag/case
VIDEO SMALL BOWEL ENTEROSCOPE (USED)
PENTAX OF AMERICA, INC.
VSB-2990I
In Commercial Distribution

  • 04961333240470 ()


  • Flexible video enteroscope
HD - DIGITAL VIDEO CAPTURE
PENTAX OF AMERICA, INC.
9310HD
In Commercial Distribution

  • 04961333236770 ()


  • Video cassette recorder
HL7 INTERFACE OUTBOUND
PENTAX OF AMERICA, INC.
9269
In Commercial Distribution

  • 04961333236763 ()


  • Radiology information system
HL7 INTERFACE INBOUND
PENTAX OF AMERICA, INC.
9267
In Commercial Distribution

  • 04961333236756 ()


  • Radiology information system
ENDOPORTAL UPGRADE
PENTAX OF AMERICA, INC.
9265
In Commercial Distribution

  • 04961333236749 ()


  • Radiology information system
ENDOPORTAL
PENTAX OF AMERICA, INC.
9263
In Commercial Distribution

  • 04961333236732 ()


  • Radiology information system
DICOM INTERFACE FOR STROBE
PENTAX OF AMERICA, INC.
9251
In Commercial Distribution

  • 04961333236725 ()


  • Radiology information system
VOICE ANALYSIS PROGRAM
PENTAX OF AMERICA, INC.
9223
In Commercial Distribution

  • 04961333236718 ()


  • Electroglottograph
DICOM INTERFACE FOR SWALLOWING
PENTAX OF AMERICA, INC.
7251
In Commercial Distribution

  • 04961333236701 ()


  • Radiology information system
COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device
VISI-PITCH (SOFTWARE)
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333236572 ()


  • Speech assistive training device
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333236565 ()


  • Electroglottograph
NASOMETER II (SOFTWARE)
PENTAX OF AMERICA, INC.
6450
In Commercial Distribution

  • 04961333236558 ()


  • Electroglottograph
COMPUTERIZED SPEECH LAB
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333235445 ()


  • Speech assistive training device
VISI-PITCH
PENTAX OF AMERICA, INC.
3950C
In Commercial Distribution

  • 04961333235438 ()


  • Speech assistive training device
CAPE V SOFTWARE MODULE
PENTAX OF AMERICA, INC.
5168
In Commercial Distribution

  • 04961333235421 ()


  • Electroglottograph
LINEAR ULTRASOUND VIDEO GASTROSCOPE (REFURBISHED)
PENTAX OF AMERICA, INC.
EG-3270UK
In Commercial Distribution

  • 04961333233953 ()


  • Flexible ultrasound gastroduodenoscope
C.A.P. HD DUODENOSCOPE (US NEW)
PENTAX OF AMERICA, INC.
ED34-I10T-US
In Commercial Distribution

  • 04961333232956 ()


  • Flexible video duodenoscope, reusable
SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED)
PENTAX OF AMERICA, INC.
VSB-3430K
In Commercial Distribution

  • 04961333232925 ()


  • Flexible video enteroscope
OTOSCOPE SHEATH
PENTAX OF AMERICA, INC.
8869
In Commercial Distribution

  • 04961333232888 ()


  • Rigid optical nasopharyngoscope
ADAPTABLE TUBE
PENTAX OF AMERICA, INC.
8859
Not in Commercial Distribution

  • 04961333232871 ()


  • Rigid optical nasopharyngoscope
ADAPTABLE TUBE
PENTAX OF AMERICA, INC.
8858
Not in Commercial Distribution

  • 04961333232864 ()


  • Rigid optical nasopharyngoscope
SUCTION/IRRIGATION HANDLE
PENTAX OF AMERICA, INC.
8857
In Commercial Distribution

  • 04961333232857 ()


  • Rigid optical nasopharyngoscope
FLAT HANDLE FOR 4.0MM
PENTAX OF AMERICA, INC.
8849
Not in Commercial Distribution

  • 04961333232840 ()


  • Rigid optical nasopharyngoscope
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