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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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Surgical Direct - B382SD40909B0

Cysto-Urethroscope Sheath with Obturator
Surgical Direct, Inc.
SD40909B
In Commercial Distribution

  • B382SD40909B0 ()
SD40909B

  • Rigid optical cystoscope

Arthrex® - 00888867020825

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

  • 00888867020825 ()
AR-1678-01

  • Surgical drill guide, reusable

StimRouter Clinician's Kit - 00815962020023

Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use

Arthrex® - 00888867010086

SCREWDRIVER WITH AO CONNECTION
ARTHREX, INC.
AR-13223
In Commercial Distribution

  • 00888867010086 ()
AR-13223

  • Surgical screwdriver, 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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