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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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No Description
Diagnostic Group LLC
GSI AMTAS Flex
In Commercial Distribution

  • 00810046700266 ()


  • Tone audiometer
No Description
Diagnostic Group LLC
GSI AMTAS Flex
In Commercial Distribution

  • 00810046700235 ()


  • Tone audiometer
No Description
Diagnostic Group LLC
GSI Pello
In Commercial Distribution

  • 00810046700075 ()


  • Tone audiometer
No Description
Diagnostic Group LLC
GSI 18
In Commercial Distribution

  • 00810046700006 ()


  • Tone audiometer
No Description
MEDRX, INC.
MedRx AWRC
In Commercial Distribution

  • 00810044583045 ()


  • Tone audiometer
No Description
MEDRX, INC.
MedRx Kiosk
In Commercial Distribution

  • 00810044582963 ()


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

  • 00810044580112 ()


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

  • 00810044580082 ()


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

  • 00810044580044 ()


  • Tone audiometer
No Description
MEDRX, INC.
Avant ARC
In Commercial Distribution

  • 00810044580013 ()


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

  • 00810044580006 ()


  • Tone audiometer
Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software
EleVation™ Breast Biopsy System Driver Loaner
Bard Peripheral Vascular, Inc.
EVLOANER
In Commercial Distribution

  • 00801741182471 ()
EVLOANER

  • Mammographic stereotactic biopsy system
EleVation™ Breast Biopsy System Driver Refurbished
Bard Peripheral Vascular, Inc.
EVREFURB
In Commercial Distribution

  • 00801741182464 ()
EVREFURB

  • Mammographic stereotactic biopsy system
EleVation™ Breast Biopsy System Driver
Bard Peripheral Vascular, Inc.
EVDRIVER
In Commercial Distribution

  • 00801741182365 ()
EVDRIVER

  • Mammographic stereotactic biopsy system
NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system
NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Footswitch For use with EnCor® System
SENORX, INC.
FSENCOR01
In Commercial Distribution

  • 00801741086557 ()
FSENCOR01

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System MRI Footswitch
SENORX, INC.
FSENCORMR
In Commercial Distribution

  • 00801741086540 ()
FSENCORMR

  • Mammographic stereotactic biopsy system
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® Breast Biopsy System Fire Forward Accessory
SENORX, INC.
ENCFF02
In Commercial Distribution

  • 00801741086458 ()
ENCFF02

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Fire Forward Adapter Accessory
SENORX, INC.
ENCFF01
Not in Commercial Distribution

  • 00801741086441 ()
ENCFF01

  • Mammographic stereotactic biopsy system
ENCOR ULTRA® Breast Biopsy System
SENORX, INC.
E5115
In Commercial Distribution

  • 00801741086137 ()
E5115

  • Mammographic stereotactic biopsy system
ENCOR ENSPIRE® Breast Biopsy System
SENORX, INC.
E4115
In Commercial Distribution

  • 00801741086113 ()
E4115

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System MRI Driver
SENORX, INC.
DRENCORMR
In Commercial Distribution

  • 00801741086083 ()
DRENCORMR

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Driver
SENORX, INC.
DRENCOR
In Commercial Distribution

  • 00801741086076 ()
DRENCOR

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Control Module
SENORX, INC.
CM3000
Not in Commercial Distribution

  • 00801741086052 ()
CM3000

  • Mammographic stereotactic biopsy system
ENCOR ENSPIRE® Breast Biopsy System Driver Holder
SENORX, INC.
AC4001
In Commercial Distribution

  • 00801741085956 ()
AC4001

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Vacuum System
SENORX, INC.
VS3000
Not in Commercial Distribution

  • 00801741086755 ()
VS3000

  • Mammographic stereotactic biopsy system
ENCOR® Breast Biopsy System Vacuum Package
SENORX, INC.
SCVACPAK3000
In Commercial Distribution

  • 00801741086731 ()
SCVACPAK3000

  • Mammographic stereotactic biopsy system
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