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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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PERLA TL - 07640375236166

HEAD ALIGNER WITH T-HANDLE
SpineArt SA
SPE-US 01 43-N
In Commercial Distribution

  • 07640375236166 ()
SPE-US 01 43-N

  • Surgical implant/trial-implant/sizer holder, reusable

Arthrex® - 00888867020825

DRILL GUIDE WITH TEETH
ARTHREX, INC.
AR-1678-01
In Commercial Distribution

  • 00888867020825 ()
AR-1678-01

  • Surgical drill guide, reusable

Arthrex® - 00888867200708

MOTOR WITH CABLE 3.5M
ARTHREX, INC.
AR-200M
In Commercial Distribution

  • 00888867200708 ()
AR-200M

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Arthrex® - 00888867190962

Punch with cortical tap
ARTHREX, INC.
AR-1927CTB-2
In Commercial Distribution

  • 00888867190962 ()
AR-1927CTB-2

  • Bone tap, reusable

Kobold® Vaginal Cylinder Applicator Set (E) - 00815568020991

Labelled with CE mark
KOBOLD, LLC
715-000
In Commercial Distribution

  • 00815568020991 ()


  • Vaginal brachytherapy system applicator, remote-afterloading

Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) - 00815568020984

Labelled with CE mark
KOBOLD, LLC
708-002
In Commercial Distribution

  • 00815568020984 ()

  • Cylinder-shaped ovoids


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) - 00815568020977

Labelled with CE mark
KOBOLD, LLC
708-001
In Commercial Distribution

  • 00815568020977 ()

  • Barrel-shaped ovoids


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 30 Deg Ring Applicator Set (E) - 00815568020960

Labelled with CE mark
KOBOLD, LLC
707-004
In Commercial Distribution

  • 00815568020960 ()

  • Angle: 30 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 45 Deg Ring Applicator Set (E) - 00815568020953

Labelled with CE mark
KOBOLD, LLC
707-003
In Commercial Distribution

  • 00815568020953 ()

  • Angle: 45 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 60 Deg Ring Applicator Set (E) - 00815568020946

Labelled with CE mark
KOBOLD, LLC
707-002
In Commercial Distribution

  • 00815568020946 ()

  • Angle: 60 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading
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