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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® Ti6® The screw removal tool is used in conjunction with the Integra Ti6 Screw system.
Ascension Orthopedics, Inc.
FS1040
In Commercial Distribution

  • M269FS10401 ()
  • 10381780244950 ()

  • 5.4 in L
FS1040

  • Orthopaedic inorganic implant inserter/extractor, reusable
The titanium swivel driver handle is useful for inserting small screws.
Ascension Orthopedics, Inc.
FS1005
In Commercial Distribution

  • M269FS10051 ()
  • 10381780244899 ()

  • 4.08 in L
FS1005

  • Surgical instrument handle, non-torque-limiting
Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-50
Not in Commercial Distribution

  • M269DRL5010501 ()
  • 10381780244691 ()

  • 6.72 in L
DRL501050

  • Cannulated surgical drill bit, single-use
Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-5010-32
Not in Commercial Distribution

  • M269DRL5010321 ()
  • 10381780244684 ()

  • 6.72 in L
DRL501032

  • Cannulated surgical drill bit, single-use
Construct® Ankle Fusion Plate System The drill bit is a cutting tool used to create cylindrical holes.
Ascension Orthopedics, Inc.
DRL-1000-32
Not in Commercial Distribution

  • M269DRL1000321 ()
  • 10381780244677 ()

  • 10.21 in L
DRL100032

  • Cannulated surgical drill bit, single-use
Integra® DigiFuse® The ratchet handle is used in conjunction with the Integra DigiFuse system.
Ascension Orthopedics, Inc.
DF1500
In Commercial Distribution

  • M269DF15001 ()
  • 10381780244424 ()

  • 5.496 in L
DF1500

  • Surgical instrument handle, non-torque-limiting
Titan™ Reverse Shoulder System The stem depth stop is used with the Titan Reverse Shoulder system.
Ascension Orthopedics, Inc.
DEP096006901
In Commercial Distribution

  • M269DEP0960069011 ()
  • 10381780244417 ()

  • .76 in W
DEP-0960-069-01

  • Surgical depth gauge, reusable
Titan™ Reverse Shoulder System The double drill guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DDG096007701
In Commercial Distribution

  • M269DDG0960077011 ()
  • 10381780244394 ()

  • 6.00 in L
DDG-0960-077-01

  • Surgical drill guide, reusable
Integra® Silicone PIP Starter Awl The Starter Awl is used to penetrate the articular surface and expose the canal of the metacarpal and phalangeal bone.
Ascension Orthopedics, Inc.
AWL-520-01
In Commercial Distribution

  • M269AWL520011 ()
  • 10381780242178 ()

  • 7.53 in L
AWL-520-01

  • Orthopaedic knife
Central Anti-Rotation Peg
Ascension Orthopedics, Inc.
PEG-0926-000
In Commercial Distribution

  • M269PEG09260001 ()
  • 10381780258346 ()

  • 1.13 in L


  • Orthopaedic implant-instrument extension adaptor, reusable
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