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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VIDEO DUODENOSCOPE - I10 STANDARD (INTERNATIONAL USED)
PENTAX OF AMERICA, INC.
ED34-I10T
In Commercial Distribution

  • 04961333240128 ()


  • Flexible video duodenoscope, reusable
VIDEO CYSTOSCOPE 2.0C 5.5TP 400L (USED)
PENTAX OF AMERICA, INC.
ECY-1575K
In Commercial Distribution

  • 04961333240111 ()


  • Flexible video cystoscope, reusable
VIDEO COLONOSCOPE (USED)
PENTAX OF AMERICA, INC.
EC38-I10NL
In Commercial Distribution

  • 04961333240104 ()


  • Flexible video colonoscope, reusable
VIDEO COLONOSCOPE (USED)
PENTAX OF AMERICA, INC.
EC34-I10TL
In Commercial Distribution

  • 04961333240098 ()


  • Flexible video colonoscope, reusable
VIDEO BRONCHOSCOPE (USED)
PENTAX OF AMERICA, INC.
EB19-J10
In Commercial Distribution

  • 04961333240081 ()


  • Flexible video bronchoscope, reusable
VIDEO BRONCHOSCOPE (USED)
PENTAX OF AMERICA, INC.
EB15-J10
In Commercial Distribution

  • 04961333240074 ()


  • Flexible video bronchoscope, reusable
VIDEO PROCESSOR (FOR VIVIDEO) (USED)
PENTAX OF AMERICA, INC.
CP-1000
In Commercial Distribution

  • 04961333240067 ()


  • Endoscopic video image processing unit
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
ROUND HANDLE FOR 4.0MM
PENTAX OF AMERICA, INC.
8848
Not in Commercial Distribution

  • 04961333232833 ()


  • Rigid optical nasopharyngoscope
FLAT HANDLE FOR 2.7MM
PENTAX OF AMERICA, INC.
8847
Not in Commercial Distribution

  • 04961333232826 ()


  • Rigid optical nasopharyngoscope
ROUND HANDLE FOR 2.7MM
PENTAX OF AMERICA, INC.
8846
Not in Commercial Distribution

  • 04961333232819 ()


  • Rigid optical nasopharyngoscope
FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
PENTAX OF AMERICA, INC.
FNL-7RP3
In Commercial Distribution

  • 04961333232796 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
PENTAX OF AMERICA, INC.
FNL-15RP3
In Commercial Distribution

  • 04961333232789 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
PENTAX OF AMERICA, INC.
FNL-10RP3
In Commercial Distribution

  • 04961333232772 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
NASO-PHARYNGO-LRNGO PORTABLE (REFURBISHED)
PENTAX OF AMERICA, INC.
FNL-10BS
Not in Commercial Distribution

  • 04961333232765 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
FIBER NASO PHARYNGO LARYNGOSCOPE INTUB 3 (REFURBISHED)
PENTAX OF AMERICA, INC.
FNL-10AP
Not in Commercial Distribution

  • 04961333232758 ()


  • Flexible fibreoptic nasopharyngolaryngoscope
FIBER TRANS N ESOPH (REFURBISHED)
PENTAX OF AMERICA, INC.
FE-15W
Not in Commercial Distribution

  • 04961333232741 ()


  • Flexible fibreoptic oesophagoscope
FIBER OPTIC CYSTOSCOPE 2.2C 4.8TP 400L (REFURBISHED)
PENTAX OF AMERICA, INC.
FCY-15P2
Not in Commercial Distribution

  • 04961333232734 ()


  • Flexible fibreoptic cystoscope
FIBER COLONOSCOPE (REFURBISHED)
PENTAX OF AMERICA, INC.
FC-38FV2
Not in Commercial Distribution

  • 04961333232710 ()


  • Flexible fibreoptic colonoscope
FIBER COLONOSCOPE SD12.8,CD3.8 (REFURBISHED)
PENTAX OF AMERICA, INC.
FC-38FV
Not in Commercial Distribution

  • 04961333232703 ()


  • Flexible fibreoptic colonoscope
FIBEROPTIC BRONCHOSCOPE 1.2C 2.7TP 600L (REFURBISHED)
PENTAX OF AMERICA, INC.
FB-8V
In Commercial Distribution

  • 04961333232697 ()


  • Flexible fibreoptic bronchoscope
FIBEROPTIC BRONCHOSCOPE 2.8C 5.9TP 600L (REFURBISHED)
PENTAX OF AMERICA, INC.
FB-18V
In Commercial Distribution

  • 04961333232680 ()


  • Flexible fibreoptic bronchoscope
FIBER BRONCHOSCOPE TD5.9,CD2.8 (REFURBISHED)
PENTAX OF AMERICA, INC.
FB-18P
Not in Commercial Distribution

  • 04961333232673 ()


  • Flexible fibreoptic bronchoscope
FIBEROPTIC BRONCHOSCOPE 2.2C 4.9TP 600L (REFURBISHED)
PENTAX OF AMERICA, INC.
FB-15V
In Commercial Distribution

  • 04961333232666 ()


  • Flexible fibreoptic bronchoscope
FIBER BRONCHOSCOPE (REFURBISHED)
PENTAX OF AMERICA, INC.
FB-15P
Not in Commercial Distribution

  • 04961333232659 ()


  • Flexible fibreoptic bronchoscope
VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ (REFURBISHED)
PENTAX OF AMERICA, INC.
ES-3870K
In Commercial Distribution

  • 04961333232642 ()


  • Flexible video gastroscope, reusable
VIDEO SIGMOIDOSCOPES (REFURBISHED)
PENTAX OF AMERICA, INC.
ES-3830K
Not in Commercial Distribution

  • 04961333232635 ()


  • Flexible video gastroscope, reusable
VIDEO PROCESSOR (REFURBISHED)
PENTAX OF AMERICA, INC.
EPM-3500
Not in Commercial Distribution

  • 04961333232628 ()


  • Endoscopic video image processing unit
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