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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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ENCOR® - 00801741086458

ENCOR® Breast Biopsy System Fire Forward Accessory
SENORX, INC.
ENCFF02
In Commercial Distribution

  • 00801741086458 ()
ENCFF02

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086441

ENCOR® Breast Biopsy System Fire Forward Adapter Accessory
SENORX, INC.
ENCFF01
Not in Commercial Distribution

  • 00801741086441 ()
ENCFF01

  • Mammographic stereotactic biopsy system

ENCOR ULTRA® - 00801741086137

ENCOR ULTRA® Breast Biopsy System
SENORX, INC.
E5115
In Commercial Distribution

  • 00801741086137 ()
E5115

  • Mammographic stereotactic biopsy system

ENCOR ENSPIRE® - 00801741086113

ENCOR ENSPIRE® Breast Biopsy System
SENORX, INC.
E4115
In Commercial Distribution

  • 00801741086113 ()
E4115

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086083

ENCOR® Breast Biopsy System MRI Driver
SENORX, INC.
DRENCORMR
In Commercial Distribution

  • 00801741086083 ()
DRENCORMR

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086076

ENCOR® Breast Biopsy System Driver
SENORX, INC.
DRENCOR
In Commercial Distribution

  • 00801741086076 ()
DRENCOR

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086052

ENCOR® Breast Biopsy System Control Module
SENORX, INC.
CM3000
Not in Commercial Distribution

  • 00801741086052 ()
CM3000

  • Mammographic stereotactic biopsy system

ENCOR ENSPIRE® - 00801741085956

ENCOR ENSPIRE® Breast Biopsy System Driver Holder
SENORX, INC.
AC4001
In Commercial Distribution

  • 00801741085956 ()
AC4001

  • Mammographic stereotactic biopsy system

Eye Tracker Camera - 07090042052023

No Description
Nordicneurolab AS
ETC 2.0
In Commercial Distribution

  • 07090042052023 ()


  • Eye movement analysis system

EleVation™ - 00801741182471

EleVation™ Breast Biopsy System Driver Loaner
Bard Peripheral Vascular, Inc.
EVLOANER
In Commercial Distribution

  • 00801741182471 ()
EVLOANER

  • Mammographic stereotactic biopsy system

EleVation™ - 00801741182464

EleVation™ Breast Biopsy System Driver Refurbished
Bard Peripheral Vascular, Inc.
EVREFURB
In Commercial Distribution

  • 00801741182464 ()
EVREFURB

  • Mammographic stereotactic biopsy system

EleVation™ - 00801741182365

EleVation™ Breast Biopsy System Driver
Bard Peripheral Vascular, Inc.
EVDRIVER
In Commercial Distribution

  • 00801741182365 ()
EVDRIVER

  • Mammographic stereotactic biopsy system

IPS CaseDesigner® - 07332747197518

IPS CaseDesigner 2.4 for MAC
Nobel Biocare AB
2.4
In Commercial Distribution

  • 07332747197518 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747181937

DTX Studio Implant 3.6 for Windows 64-bit
Nobel Biocare AB
3.6
In Commercial Distribution

  • 07332747181937 ()
300843

  • Dental treatment application software

IPS CaseDesigner® - 07332747181913

IPS CaseDesigner 2.2 Win 64-bit
Nobel Biocare AB
2.2
In Commercial Distribution

  • 07332747181913 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747202878

IPS CaseDesigner 2.6 for MAC
Nobel Biocare AB
2.6
In Commercial Distribution

  • 07332747202878 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747202861

IPS CaseDesigner 2.6 for Windows 64-bit
Nobel Biocare AB
2.6
In Commercial Distribution

  • 07332747202861 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747199079

IPS CaseDesigner 2.5 for MAC
Nobel Biocare AB
2.5
In Commercial Distribution

  • 07332747199079 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747199062

IPS CaseDesigner 2.5 for Windows 64-bit
Nobel Biocare AB
2.5
In Commercial Distribution

  • 07332747199062 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747197525

IPS CaseDesigner 2.4 for Windows 64-bit
Nobel Biocare AB
2.4
In Commercial Distribution

  • 07332747197525 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747185836

IPS CaseDesigner 2.3 Mac
Nobel Biocare AB
2.3
In Commercial Distribution

  • 07332747185836 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747185829

IPS CaseDesigner 2.3 Win 64-bit
Nobel Biocare AB
2.3
In Commercial Distribution

  • 07332747185829 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747181944

DTX Studio Implant 3.6 for Mac
Nobel Biocare AB
3.6
In Commercial Distribution

  • 07332747181944 ()
300843

  • Dental treatment application software

IPS CaseDesigner® - 07332747181920

IPS CaseDesigner 2.2 Mac
Nobel Biocare AB
2.2
In Commercial Distribution

  • 07332747181920 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747178258

IPS CaseDesigner 2.1 Mac
Nobel Biocare AB
2.1
Not in Commercial Distribution

  • 07332747178258 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747178241

IPS CaseDesigner 2.1 Win 64-bit
Nobel Biocare AB
2.1
Not in Commercial Distribution

  • 07332747178241 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747172829

DTX Studio Implant 3.5 for Mac
Nobel Biocare AB
3.5
In Commercial Distribution

  • 07332747172829 ()
300843

  • Dental treatment application software

DTX Studio™ Implant - 07332747172805

DTX Studio Implant 3.5 for Windows 64-bit
Nobel Biocare AB
3.5
In Commercial Distribution

  • 07332747172805 ()
300843

  • Dental treatment application software

IPS CaseDesigner® - 07332747172065

IPS CaseDesigner 2.0 Mac
Nobel Biocare AB
2.0
Not in Commercial Distribution

  • 07332747172065 ()
300011

  • Dental treatment application software

IPS CaseDesigner® - 07332747172058

IPS CaseDesigner 2.0 Win 64-bit
Nobel Biocare AB
2.0
Not in Commercial Distribution

  • 07332747172058 ()
300011

  • Dental treatment application software

DTX Studio™ Implant - 07332747166125

DTX Studio Implant 3.4 for Mac
Nobel Biocare AB
3.4
In Commercial Distribution

  • 07332747166125 ()
300843

  • Dental treatment application software

DTX Studio™ Implant - 07332747166101

DTX Studio Implant 3.4 for Win 64-bit
Nobel Biocare AB
3.4
In Commercial Distribution

  • 07332747166101 ()
300843

  • Dental treatment application software

MSOFT Dental Planning System - 07629999685093

No Description
Swissmeda AG
2.16
Not in Commercial Distribution

  • 07629999685093 ()


  • Dental treatment application software

MSOFT Dental Planning System - 07629999628410

No Description
Swissmeda AG
2.19.0
In Commercial Distribution

  • 07629999628410 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999614178

No Description
Swissmeda AG
2.17.1
In Commercial Distribution

  • 07629999614178 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999065512

No Description
Swissmeda AG
2.15.4
In Commercial Distribution

  • 07629999065512 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999062177

No Description
Swissmeda AG
2.20.0
In Commercial Distribution

  • 07629999062177 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999061569

No Description
Swissmeda AG
2.15.3
Not in Commercial Distribution

  • 07629999061569 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999057654

No Description
Swissmeda AG
2.15.2
Not in Commercial Distribution

  • 07629999057654 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999056985

No Description
Swissmeda AG
2.15.1
Not in Commercial Distribution

  • 07629999056985 ()


  • Dental treatment application software
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