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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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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

NobelClinician® - 07332747128970

NobelClinician 3.2 for MAC
Nobel Biocare AB
3.2
Not in Commercial Distribution

  • 07332747128970 ()
101560

  • Dental treatment application software

NobelClinician® - 07332747128963

NobelClinician 3.2 for Windows 64-bit
Nobel Biocare AB
3.2
Not in Commercial Distribution

  • 07332747128963 ()
101560

  • Dental treatment application software

IPS CaseDesigner™ - 07332747126976

IPS CaseDesigner 1.3 for MAC
Nobel Biocare AB
1.3
Not in Commercial Distribution

  • 07332747126976 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747126969

IPS CaseDesigner 1.3 for Windows 64-bit
Nobel Biocare AB
1.3
Not in Commercial Distribution

  • 07332747126969 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747125009

IPS CaseDesigner 1.2 for MAC
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747125009 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747124996

IPS CaseDesigner 1.2 for Windows 64-bit
Nobel Biocare AB
1.2
Not in Commercial Distribution

  • 07332747124996 ()
300011

  • Dental treatment application software

MedRx - 00810044583045

No Description
MEDRX, INC.
MedRx AWRC
In Commercial Distribution

  • 00810044583045 ()


  • Tone audiometer

MedRx - 00810044580112

No Description
MEDRX, INC.
Avant AIR+
In Commercial Distribution

  • 00810044580112 ()


  • Tone audiometer

MedRx - 00810044580082

No Description
MEDRX, INC.
MedRx Tinnometer
Not in Commercial Distribution

  • 00810044580082 ()


  • Tone audiometer

MedRx - 00810044580044

No Description
MEDRX, INC.
Avant Stealth Audiometer
In Commercial Distribution

  • 00810044580044 ()


  • Tone audiometer

MedRx - 00810044580013

No Description
MEDRX, INC.
Avant ARC
In Commercial Distribution

  • 00810044580013 ()


  • Tone audiometer

MedRx - 00810044580006

No Description
MEDRX, INC.
Avant A2D+
In Commercial Distribution

  • 00810044580006 ()


  • Tone audiometer

MedRx - 00810044582963

No Description
MEDRX, INC.
MedRx Kiosk
In Commercial Distribution

  • 00810044582963 ()


  • Tone audiometer

ENCOR® - 00801741086755

ENCOR® Breast Biopsy System Vacuum System
SENORX, INC.
VS3000
Not in Commercial Distribution

  • 00801741086755 ()
VS3000

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086731

ENCOR® Breast Biopsy System Vacuum Package
SENORX, INC.
SCVACPAK3000
In Commercial Distribution

  • 00801741086731 ()
SCVACPAK3000

  • Mammographic stereotactic biopsy system

ENCOR ULTRA® - 00801741086724

ENCOR ULTRA® Breast Biopsy System Vacuum Tubing
SENORX, INC.
SCTUB4000
In Commercial Distribution

  • 10801741086721 ()
  • 00801741086724 ()
SCTUB4000

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086717

ENCOR® Breast Biopsy System Vacuum Tubing Set
SENORX, INC.
SCTUB3000
In Commercial Distribution

  • 10801741086714 ()
  • 00801741086717 ()
SCTUB3000

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086557

ENCOR® Breast Biopsy System Footswitch For use with EnCor® System
SENORX, INC.
FSENCOR01
In Commercial Distribution

  • 00801741086557 ()
FSENCOR01

  • Mammographic stereotactic biopsy system

ENCOR® - 00801741086540

ENCOR® Breast Biopsy System MRI Footswitch
SENORX, INC.
FSENCORMR
In Commercial Distribution

  • 00801741086540 ()
FSENCORMR

  • Mammographic stereotactic biopsy system

EnCor - 00801741086496

EnCor Breast Biopsy System Needle Guide (Fischer) For use with Fischer Stereotactic Imaging Tables
SENORX, INC.
ENCFNGUIDE01
In Commercial Distribution

  • 00801741086496 ()
ENCFNGUIDE01

  • Mammographic stereotactic biopsy system

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

VACORA® - 00801741079719

VACORA® Vacuum Assisted Biopsy System, Adapter Siemens™ Stereotactic Systems
Bard Peripheral Vascular, Inc.
VA1SI
Not in Commercial Distribution

  • 00801741079719 ()
VA1SI

  • Mammographic stereotactic biopsy system

VACORA® - 00801741079702

VACORA® Vacuum Assisted Biopsy System, Adapter Plate Siemens™ MRI Systems
Bard Peripheral Vascular, Inc.
VA1MRSI
Not in Commercial Distribution

  • 00801741079702 ()
VA1MRSI

  • Mammographic stereotactic biopsy system

VACORA® - 00801741079696

VACORA® Vacuum Assisted Biopsy System, Adapter Plate Siemens™ MammoTest™ Stereotactic Table
Bard Peripheral Vascular, Inc.
VA1MA
Not in Commercial Distribution

  • 00801741079696 ()
VA1MA

  • Mammographic stereotactic biopsy system

VACORA® - 00801741079689

VACORA® Vacuum Assisted Biopsy System, Adapter Plate Lorad™ Stereotactic Table
Bard Peripheral Vascular, Inc.
VA1LO
Not in Commercial Distribution

  • 00801741079689 ()
VA1LO

  • Mammographic stereotactic biopsy system

VACORA® - 00801741079672

VACORA® Vacuum Assisted Biopsy System
Bard Peripheral Vascular, Inc.
VF2019
Not in Commercial Distribution

  • 00801741079672 ()
VF2019

  • Mammographic stereotactic biopsy system

VACORA® - 00801741079542

VACORA® Vacuum Assisted Biopsy System, Distance Ring 14G x 10 mm
Bard Peripheral Vascular, Inc.
VBD1410
Not in Commercial Distribution

  • 10801741079549 ()
  • 00801741079542 ()

  • 14 Gauge
  • Length: 10 Millimeter
VBD1410

  • Mammographic stereotactic biopsy system

VACORA® - 00801741079535

VACORA® Vacuum Assisted Biopsy System, Distance Ring 10G x 10 mm
Bard Peripheral Vascular, Inc.
VBD1010
Not in Commercial Distribution

  • 10801741079532 ()
  • 00801741079535 ()

  • Length: 10 Millimeter
  • 10 Gauge
VBD1010

  • Mammographic stereotactic biopsy system
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