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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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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
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