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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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Integra® First Choice® DRUJ System MUH Resection Guide The Modular Ulnar Head Resection Guide is placed against the distal ulna to determine a standard, medium, or long resection of the ulnar head.
Ascension Orthopedics, Inc.
OSG60000
In Commercial Distribution

  • M269OSG600001 ()
  • 10381780246480 ()

  • 4.7 in L x 1.5 in W
OSG-600-00

  • Custom-made orthopaedic/craniofacial surgical guide
Surgical Instruments Trial Extractor
Ascension Orthopedics, Inc.
EXT20000
In Commercial Distribution

  • M269EXT200001 ()
  • 10381780244868 ()

  • 5.25 in L x 2.67 in W
EXT-200-00

  • Orthopaedic inorganic implant inserter/extractor, reusable
Construct® Ankle Fusion Plate System The double drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DDG-5010-01
Not in Commercial Distribution

  • M269DDG5010011 ()
  • 10381780244400 ()

  • 5.92 in L x 2.16 in W
DDG501001

  • Surgical drill guide, reusable
CAPTURE™ High Torque Screw System The Capture 7.0mm Instrument Drop Plate is a separate tray within the base where devices are held.
Ascension Orthopedics, Inc.
CSA-5000-006
In Commercial Distribution

  • M269CSA50000061 ()
  • 10381780243687 ()

  • 12.47 in L x 7.35 in W
CSA5000006

  • Instrument tray, reusable
Integra® Surgical Instruments The Instrument Case Lid is the top part of the case which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA00007
In Commercial Distribution

  • M269CSA000071 ()
  • 10381780242963 ()

  • 20.72 in L x 9.92 in W
CSA-000-07

  • Instrument tray, reusable
Surgical Instruments Case Lid
Ascension Orthopedics, Inc.
CSA00004
In Commercial Distribution

  • M269CSA000041 ()
  • 10381780242949 ()

  • 20.66 in L x 9.91 in W
CSA-000-04

  • Instrument tray, reusable
Construct® Ankle Fusion Plate System The compression drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
CDG-5010-01
Not in Commercial Distribution

  • M269CDG5010011 ()
  • 10381780242802 ()

  • 5.46 in L x 2.160 in W
CDG501001

  • Surgical drill guide, reusable
Integra® Total Foot System Cone Spherical Reamer Sz. 24mm The Cone cannulated reamer is intended for preparing the MTP joint for fusion and providing an accurate anatomic fit.
Ascension Orthopedics, Inc.
CCR8950224
In Commercial Distribution

  • M269CCR89502241 ()
  • 10381780242796 ()

  • 3.38 in L x .909 in dia
CCR-895-02-24

  • Bone-resection orthopaedic reamer, reusable
Integra® Total Foot System Cone Spherical Reamer Sz. 21mm The Cone cannulated reamer is intended for preparing the MTP joint for fusion and providing an accurate anatomic fit.
Ascension Orthopedics, Inc.
CCR8950221
In Commercial Distribution

  • M269CCR89502211 ()
  • 10381780242789 ()

  • 3.33 in L x .789 in dia
CCR-895-02-21

  • Bone-resection orthopaedic reamer, reusable
Integra® Total Foot System Cone Spherical Reamer Sz. 19mm The Cone cannulated reamer is intended for preparing the MTP joint for fusion and providing an accurate anatomic fit.
Ascension Orthopedics, Inc.
CCR8950219
In Commercial Distribution

  • M269CCR89502191 ()
  • 10381780242772 ()

  • 3.30 in L x .714 in dia
CCR-895-02-19

  • Bone-resection orthopaedic reamer, reusable
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