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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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Arthrex® - 00888867018556

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

  • 00888867018556 ()
AR-1529

  • Orthopaedic graft tensioner, reusable

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® 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 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

Arthrex® - 00888867010086

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

  • 00888867010086 ()
AR-13223

  • Surgical screwdriver, reusable

Arthrex® - 00888867308459

ACL TightRope with FiberTag
ARTHREX, INC.
AR-1588RTT
In Commercial Distribution

  • 00888867308459 ()
AR-1588RTT

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867293496

FastPass SCORPION-mf with FlushPort
ARTHREX, INC.
AR-13997MFF
In Commercial Distribution

  • 00888867293496 ()
AR-13997MFF

  • Suturing unit, reusable

Arthrex® - 00888867293380

Curved Scorpion with FlushPort
ARTHREX, INC.
AR-13998CF
In Commercial Distribution

  • 00888867293380 ()
AR-13998CF

  • Suturing unit, reusable

Arthrex® - 00888867293328

NanoRetriever, 130mm with FlushPort
ARTHREX, INC.
AR-10914F
In Commercial Distribution

  • 10888867293325 ()
  • 00888867293328 ()
AR-10914F

  • Suturing unit, 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
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