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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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Ascension® MCP The MCP X-ray template is used for size assessment.
Ascension Orthopedics, Inc.
TMP-100-00
In Commercial Distribution

  • M269TMP100001 ()
  • 10381780247616 ()

  • NA
TMP-100-00

  • Surgical implant template, reusable
Integra®Surgical Instruments The slap hammer is used to apply force.
Ascension Orthopedics, Inc.
SLP1002519
In Commercial Distribution

  • M269SLP10025191 ()
  • 10381780247463 ()

  • 290 mm L
SLP-1002-519

  • Orthopaedic implant impactor, reusable
Integra®Surgical Instruments The ratchet t-handle is provided with quick connect.
Ascension Orthopedics, Inc.
NR135004J004
In Commercial Distribution

  • M269NR135004J0041 ()
  • 10381780246343 ()

  • 4.5 in L x 3.88 in W
NR135004-J-004

  • Surgical instrument handle, non-torque-limiting
Titan™ Reverse Shoulder System The handle is used to remove glenospheres.
Ascension Orthopedics, Inc.
HDL096006701
In Commercial Distribution

  • M269HDL0960067011 ()
  • 10381780245476 ()

  • 10.4 in x .255in diameter
HDL-0960-067-01

  • Surgical instrument handle, non-torque-limiting
Integra® Lunate The Lunate Base is designed to contain the instruments.
Ascension Orthopedics, Inc.
CSA71002
In Commercial Distribution

  • M269CSA710021 ()
  • 10381780243991 ()
CSA-710-02

  • Instrument tray, reusable
CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1111
In Commercial Distribution

  • M269AW11111 ()
  • 10381780242093 ()

  • 3.53 in L x .0315 in dia
AW1111

  • Orthopaedic guidewire, reusable
CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1105
In Commercial Distribution

  • M269AW11051 ()
  • 10381780242086 ()
AW1105

  • Orthopaedic guidewire, reusable
CAPTURE™ Cannulated Screw System Threaded K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1104
In Commercial Distribution

  • M269AW11041 ()
  • 10381780242079 ()

  • 4.75 in L x .0433 in dia; .24 in threaded
AW1104

  • Orthopaedic guidewire, reusable
CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1103
In Commercial Distribution

  • M269AW11031 ()
  • 10381780242062 ()

  • 4.75 in L x .0433 in dia
AW1103

  • Orthopaedic guidewire, reusable
CAPTURE™ Cannulated Screw System Smooth K-Wire is used for temporary fixation.
Ascension Orthopedics, Inc.
AW1102
In Commercial Distribution

  • M269AW11021 ()
  • 10381780242055 ()

  • 3.95 in L x .035 in dia
AW1102

  • Orthopaedic guidewire, reusable
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