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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DEMO CASE FOR LARGE CARTS (80247)
PENTAX OF AMERICA, INC.
001-007C-N
In Commercial Distribution

  • 04961333241651 ()


  • Medical capital equipment storage bag/case
DEMO CASE FOR SMALL CARTS (80242)
PENTAX OF AMERICA, INC.
001-007C
In Commercial Distribution

  • 04961333241644 ()


  • Medical capital equipment storage bag/case
ADAPTER, WTRJT-IRR TUBE
PENTAX OF AMERICA, INC.
945701
In Commercial Distribution

  • 04961333241637 ()


  • Luminal device flushing tubing set, reusable
ADAPTER,WATER/AIR
PENTAX OF AMERICA, INC.
945202
In Commercial Distribution

  • 04961333241620 ()


  • Luminal device flushing tubing set, reusable
CHANNEL SEPARATOR, PNTX
PENTAX OF AMERICA, INC.
913501
In Commercial Distribution

  • 04961333241613 ()


  • Luminal device flushing tubing set, reusable
CHANNEL SEPARTOR, PNTX
PENTAX OF AMERICA, INC.
910601
In Commercial Distribution

  • 04961333241606 ()


  • Luminal device flushing tubing set, reusable
CHANNEL CONNECTOR TUBE
PENTAX OF AMERICA, INC.
907501
In Commercial Distribution

  • 04961333241590 ()


  • Luminal device flushing tubing set, reusable
CHANNEL SEPARATOR PNTX
PENTAX OF AMERICA, INC.
905601
In Commercial Distribution

  • 04961333241583 ()


  • Luminal device flushing tubing set, reusable
CHANNEL CONNECTOR TUBE
PENTAX OF AMERICA, INC.
848102
In Commercial Distribution

  • 04961333241576 ()


  • Luminal device flushing tubing set, reusable
CONNECTOR TUBE, WATER
PENTAX OF AMERICA, INC.
845201
In Commercial Distribution

  • 04961333241569 ()


  • Luminal device flushing tubing set, reusable
CONNECTOR TUBE, BROWN
PENTAX OF AMERICA, INC.
842103
In Commercial Distribution

  • 04961333241552 ()


  • Luminal device flushing tubing set, reusable
CHANNEL CONN. TUBE, ORG
PENTAX OF AMERICA, INC.
841701
In Commercial Distribution

  • 04961333241545 ()


  • Luminal device flushing tubing set, reusable
CHANNEL CONN. TUBE, WHITE
PENTAX OF AMERICA, INC.
841401
In Commercial Distribution

  • 04961333241538 ()


  • Luminal device flushing tubing set, reusable
CHANNEL CONNECTION TUBE
PENTAX OF AMERICA, INC.
841001
In Commercial Distribution

  • 04961333241521 ()


  • Luminal device flushing tubing set, reusable
CHANNEL PLUG
PENTAX OF AMERICA, INC.
112401
In Commercial Distribution

  • 04961333241514 ()


  • Luminal device flushing tubing set, reusable
CONNTUBE
PENTAX OF AMERICA, INC.
102401
In Commercial Distribution

  • 04961333241507 ()


  • Luminal device flushing tubing set, reusable
ADAPTER, OE-C12
PENTAX OF AMERICA, INC.
102301
In Commercial Distribution

  • 04961333241491 ()


  • Luminal device flushing tubing set, reusable
ADAPTER, WTRJT CONN TUBE
PENTAX OF AMERICA, INC.
101701
In Commercial Distribution

  • 04961333241484 ()


  • Luminal device flushing tubing set, reusable
MATROX KX20 MALE TO 4 X DVI-I FEMALE CAB
PENTAX OF AMERICA, INC.
92216
In Commercial Distribution

  • 04961333241477 ()


  • Radiology information system
VIDEO CABLE FOR GMED SYSTEM
PENTAX OF AMERICA, INC.
92205
In Commercial Distribution

  • 04961333241460 ()


  • Radiology information system
CBL, USB
PENTAX OF AMERICA, INC.
92178
In Commercial Distribution

  • 04961333241453 ()


  • Radiology information system
CBL,POWER CORD AUX VIDEO INTRFC,HG
PENTAX OF AMERICA, INC.
92058
In Commercial Distribution

  • 04961333241446 ()


  • Electrical mains power cable
MEDICAL GRADE FOOTSWITCH
PENTAX OF AMERICA, INC.
90139
In Commercial Distribution

  • 04961333241439 ()


  • Foot-switch, electrical
ATEN VS162,2 PORT DVI VIDEO SPLITTERS
PENTAX OF AMERICA, INC.
90138
In Commercial Distribution

  • 04961333241422 ()


  • Radiology information system
FOOTSWITCH: MPS SINGLE PEDAL
PENTAX OF AMERICA, INC.
90108
In Commercial Distribution

  • 04961333241415 ()


  • Foot-switch, electrical
RUBBER CGI-4000 FOOTSWITCH
PENTAX OF AMERICA, INC.
90107
In Commercial Distribution

  • 04961333241408 ()


  • Foot-switch, electrical
ISOLATION TRANSFORMER 1200V 10A 4 OUTLETS
PENTAX OF AMERICA, INC.
90075
In Commercial Distribution

  • 04961333241392 ()


  • Constant-voltage transformer
FOOTSWITCH W/INTGRAL TUBING PNEUMATIC FO
PENTAX OF AMERICA, INC.
90051
In Commercial Distribution

  • 04961333241385 ()


  • Foot-switch, electrical
TUBE,CONNECTING ENDO IRRIGATOR FOR GNRTR
PENTAX OF AMERICA, INC.
90050
In Commercial Distribution

  • 04961333241378 ()
  • 14961333241375 ()


  • Electrosurgical system generator
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
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