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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® TruArch® The TruArch driver is used for insertion of the implant, as well as adjusting position.
Ascension Orthopedics, Inc.
TA-3110
Not in Commercial Distribution

  • M269TA31101 ()
  • 10381780247524 ()

  • 165.1 mm L x 4 mm dia tip
TA-3110

  • Surgical screwdriver, reusable
Titan™ Reverse Shoulder System The 2.5 Hex Driver is used to tighten 4.5mm screws.
Ascension Orthopedics, Inc.
SCR096006201
In Commercial Distribution

  • M269SCR0960062011 ()
  • 10381780247357 ()

  • 139.7 mm L x 2.5 mm hex
SCR-0960-062-01

  • Surgical screwdriver, reusable
CAPTURE™ High Torque Screw System The quick connect driver handle is attached to the appropriate hex driver to advance screws.
Ascension Orthopedics, Inc.
NR118009-J-004
In Commercial Distribution

  • M269NR118009J0041 ()
  • 10381780246336 ()
NR118009J004

  • Surgical instrument handle, non-torque-limiting
CAPTURE™ High Torque Screw System The quick connect driver handle is attached to the appropriate hex driver to advance screws.
Ascension Orthopedics, Inc.
NR115001-J-004
In Commercial Distribution

  • M269NR115001J0041 ()
  • 10381780246329 ()
NR115001J004

  • Surgical instrument handle, non-torque-limiting
Integra® MemoFix® Staple System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
MS-2630
In Commercial Distribution

  • M269MS26301 ()
  • 10381780246084 ()

  • 96.27 mm L x 2.7 mm dia tip
MS-2630

  • Cannulated surgical drill bit, single-use
Integra® MemoFix® Staple System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
MS-2620
In Commercial Distribution

  • M269MS26201 ()
  • 10381780246077 ()

  • 96.27 mm L x 2.0 mm dia tip
MS-2620

  • Cannulated surgical drill bit, single-use
Integra® MemoFix® Staple System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
MS-2610
In Commercial Distribution

  • M269MS26101 ()
  • 10381780246060 ()

  • 96.27 mm L x 1.70 mm dia tip
MS-2610

  • Cannulated surgical drill bit, single-use
Integra® External Fixation System The box wrench combination h is used to tighten parts in the external fixation system.
Ascension Orthopedics, Inc.
12224502
In Commercial Distribution

  • M269122245021 ()
  • 10381780248064 ()

  • 178 mm L; 13.0 mm openings
12224502

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The tensioner alignment tool is used in conjunction with the external fixation system.
Ascension Orthopedics, Inc.
12224300
In Commercial Distribution

  • M269122243001 ()
  • 10381780248040 ()
12224300

  • External orthopaedic fixation system, reusable
Integra® Total Foot System The TX 8 non-cannulated driver with AO is used in conjunction with the Integra Total Foot system.
Ascension Orthopedics, Inc.
TXDTFS08
In Commercial Distribution

  • M269TXDTFS081 ()
  • 10381780247876 ()

  • 3.5 in L x .13 in dia tip
TXD-TFS-08

  • Surgical screwdriver, reusable
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