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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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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

Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) - 00815568020939

Labelled with CE mark
KOBOLD, LLC
707-001
In Commercial Distribution

  • 00815568020939 ()

  • Angle: 30 degree
  • Angle: 45 degree
  • Angle: 60 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) - 00815568020922

Labelled with CE mark
KOBOLD, LLC
704-000
In Commercial Distribution

  • 00815568020922 ()


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Arthrex® - 00888867018556

SUTURE TENSIONER WITH TENSIOMETER
ARTHREX, INC.
AR-1529
In Commercial Distribution

  • 00888867018556 ()
AR-1529

  • Orthopaedic graft tensioner, reusable

Surgical Direct - B382SD12499A0

Cholangiogram Forceps with Ratchet
Surgical Direct, Inc.
SD12499A
In Commercial Distribution

  • B382SD12499A0 ()
SD12499A

  • Flexible endoscopic tissue manipulation forceps, single-use

Arthrex® - 00888867118140

DUALWAVE WITH REMOTE SET
ARTHREX, INC.
AR-6480-SR
Not in Commercial Distribution

  • 00888867118140 ()
  • M150AR6480SR0 ()
AR-6480-SR

  • Arthroscopic surgical procedure kit, non-medicated, single-use

Hip Instruments - 07630040735131

Large Blade with pins
Medacta International SA
01.15.10.0089
In Commercial Distribution

  • 07630040735131 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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