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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VIDEONISTAGMOGRAPHY SYSTEM
Ecleris
R00
In Commercial Distribution

  • B366VN1061R00 ()
VN1061

  • Electronystagmograph
MINIVAC
Ecleris
R00
In Commercial Distribution

  • B366VA16110 ()
VA16110

  • Skin abrasion unit
ECLERIS NIV HELMET
Ecleris
R00
In Commercial Distribution

  • B366U1VNI1001 ()
U1VNI1001

  • In-line CPAP set, non-nebulizing
Procam HD II
Ecleris
RX1
In Commercial Distribution

  • B366U1VI3603RX1 ()
U1VI3603

  • Surgical video camera
Procam HD CMOS II
Ecleris
R02
In Commercial Distribution

  • B366U1VI3601 ()
U1VI3601

  • Surgical video camera
Procam HD CMOS II
Ecleris
R03
In Commercial Distribution

  • B366U1VI360 ()
U1VI360

  • Surgical video camera
PROCAM FULL PAL
Ecleris
R00
In Commercial Distribution

  • B366U1VI3111 ()
U1VI3111

  • Surgical video camera
PROCAM HD BASIC
Ecleris
R00
In Commercial Distribution

  • B366U1VI2512 ()
U1VI2512

  • Surgical video camera
PROCAM BASIC PAL
Ecleris
R00
In Commercial Distribution

  • B366U1VI2511 ()
U1VI2511

  • Surgical video camera
PROCAM HD 2D
Ecleris
R00
In Commercial Distribution

  • B366U1VI2022R00 ()
U1VI2022

  • General-purpose surgical microscope
PROCAM HD 2D
Ecleris
R01
In Commercial Distribution

  • B366U1VI2021R01 ()
U1VI2021

  • General-purpose surgical microscope
PROCAM HD 2D
Ecleris
R00
In Commercial Distribution

  • B366U1VI2021 ()
U1VI2021

  • General-purpose surgical microscope
COMPUTERIZED FLOWMETER
Ecleris
RX1
In Commercial Distribution

  • B366U1RH1011 ()
U1RH1011

  • Air/gas pressure transducer
MICROSCOPE
Ecleris
R01
In Commercial Distribution

  • B366U1OM100F19LR01 ()
U1OM100F19L

  • General-purpose surgical microscope
MICROSCOPE
Ecleris
R01
In Commercial Distribution

  • B366U1OM100F19 ()
U1OM100F19

  • General-purpose surgical microscope
MICROSCOPE
Ecleris
R01
In Commercial Distribution

  • B366U1OM100F1 ()
U1OM100F1

  • General-purpose surgical microscope
MICROSCOPE
Ecleris
R00
In Commercial Distribution

  • B366U1OM100C19 ()
U1OM100C19

  • General-purpose surgical microscope
MICROSCOPE
Ecleris
R00
In Commercial Distribution

  • B366U1OM100C18LR00 ()
U1OM100C18L

  • General-purpose surgical microscope
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED121C03 ()
U1LED121C03

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED121 ()
U1LED120

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED120C11 ()
U1LED120C11

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED120 ()
U1LED120

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED111C01 ()
U1LED111C01

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED111 ()
U1LED111

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED110C08 ()
U1LED110C08

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED110 ()
U1LED110

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED100G22C08 ()
U1LED100G22C08

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED100G22C03 ()
U1LED100G22C03

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED100G22 ()
U1LED100G22

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED100G21C05 ()
U1LED100G21C05

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R00
In Commercial Distribution

  • B366U1LED100G21 ()
U1LED100G21

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R02
In Commercial Distribution

  • B366U1LED100C03 ()
U1LED100C03

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R02
In Commercial Distribution

  • B366U1LED100C01 ()
U1LED100C01

  • General-purpose light source
EVERLUX LIGHT SOURCE
Ecleris
R02
In Commercial Distribution

  • B366U1LED100 ()
U1LED100

  • General-purpose light source
PROCAM HD BASIC CONSOLE
Ecleris
R00
In Commercial Distribution

  • B366U1HC112G22 ()
U1HC112G22

  • Surgical video camera
PROCAM CONSOLE
Ecleris
R00
In Commercial Distribution

  • B366U1HC112G21 ()
U1HC112G21

  • Surgical video camera
Colposcope w/ Wall Mount & Pantographic Arm
Ecleris
RX1
In Commercial Distribution

  • B366U1C200WRX1 ()
U1C200W

  • Colposcope
Colposcope w/ Wall Mount & Pantographic Arm
Ecleris
R01
In Commercial Distribution

  • B366U1C200WR01 ()
U1C200W

  • Colposcope
Colposcope w/ Wall Mount & Pantographic Arm
Ecleris
R00
In Commercial Distribution

  • B366U1C200WR00 ()
U1C200W

  • Colposcope
Colposcope w/ Table Mount & Pantographic Arm
Ecleris
RX1
In Commercial Distribution

  • B366U1C200TRX1 ()
U1C200T

  • Colposcope
Colposcope w/ Table Mount & Pantographic Arm
Ecleris
R01
In Commercial Distribution

  • B366U1C200TR01 ()
U1C200T

  • Colposcope
Colposcope w/ Table Mount & Pantographic Arm
Ecleris
R00
In Commercial Distribution

  • B366U1C200TR00 ()
U1C200T

  • Colposcope
Colposcope w/ Floor Stand & Pantographic Arm
Ecleris
RX1
In Commercial Distribution

  • B366U1C200FRX1 ()
U1C200F

  • Colposcope
Colposcope w/ Floor Stand & Pantographic Arm
Ecleris
R01
In Commercial Distribution

  • B366U1C200FR01 ()
U1C200F

  • Colposcope
Colposcope w/ Floor Stand & Pantographic Arm
Ecleris
R00
In Commercial Distribution

  • B366U1C200FR00 ()
U1C200F

  • Colposcope
Colposcope w/ Floor Telescopic Stand
Ecleris
RX1
In Commercial Distribution

  • B366U1C200ARX1 ()
U1C200A

  • Colposcope
Colposcope w/ Floor Telescopic Stand
Ecleris
R00
In Commercial Distribution

  • B366U1C200AR00 ()
U1C200A

  • Colposcope
Colposcope w/ Wall Mount, Pantographic Arm & Inclined Binocular
Ecleris
R00
In Commercial Distribution

  • B366U1C100W3R000 ()
U1C100W3

  • Colposcope
Colposcope w/ Table Mount, Pantographic Arm & Inclined Binocular
Ecleris
R00
In Commercial Distribution

  • B366U1C100T1R000 ()
U1C100T1

  • Colposcope
HD Colposcope
Ecleris
RX1
In Commercial Distribution

  • B366U1C100FHD1RX10 ()
U1C100FHD1

  • Colposcope
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