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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® 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
Adult Quilted Briefs,Moderate
Cardinal Health, Inc.
65034
In Commercial Distribution

  • 30884521081936 ()
  • 20884521081939 ()
  • 10884521081932 ()

  • Size, 45-58, IN;
65034

  • Incontinence pants, single-use
The four hole cube is used to allow the fixation wire to be tensioned axially without deformation by the wire tensioner. The cube is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224225
In Commercial Distribution

  • 10381780125204 ()

  • 2.226 in H
12224225

  • External orthopaedic fixation system, reusable
The two hole cube is used to allow the fixation wire to be tensioned axially without deformation by the wire tensioner. The cube is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224223
In Commercial Distribution

  • 10381780125181 ()

  • 1.223 in H
12224223

  • External orthopaedic fixation system, reusable
The humeral trial inserter/extractor is used to insert the trial implant into its place, as well as extract.
Ascension Orthopedics, Inc.
IS0950046001
In Commercial Distribution

  • M269INS09500460011 ()
  • 10381780124696 ()

  • 8.3 in L
INS-0950-046-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
The humeral trial inserter/extractor is used to insert the trial implant into its place, as well as extract.
Ascension Orthopedics, Inc.
INS-0923-046-001
In Commercial Distribution

  • M269INS09230460011 ()
  • 10381780124689 ()

  • 8.4 in L
INS-0923-046-001

  • Orthopaedic inorganic implant inserter/extractor, reusable
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