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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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McKesson - 10612479230405

Impervious U-Drape 6 IN X 18.5 IN SPLIT 52 in x 48 in
MCKESSON MEDICAL-SURGICAL INC.
183-i80-09192-S
In Commercial Distribution

  • 40612479230413 ()
  • 10612479230405 ()


  • Patient surgical drape, single-use

TiWedgeTM - 10381780237471

The Integra Titanium Bone Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot. This set includes LCL trials and cotton trials to evaluate proper size and fit of the implants. A wedge inserter and tamp are also included for assistance.
Ascension Orthopedics, Inc.
TIWEDGEINSTP
Not in Commercial Distribution

  • M268TIWEDGEINSTP1 ()
  • 10381780237471 ()

  • 10.69 in L x 9.91 in W


  • General external orthopaedic fixation system implantation kit, reusable

Integra® - 10381780237457

PyroCarbon PIP Total Joint PIP Distal Template
Ascension Orthopedics, Inc.
TMP20001
In Commercial Distribution

  • M269TMP200011 ()
  • 10381780237457 ()

  • 2.378 in L x 2.418 in W
TMP-200-01

  • Surgical implant template, reusable

Movement® - 10381780237150

The Movement Great Toe proximal phalanx implant sizer allows for clear visualization of the implant size.
Ascension Orthopedics, Inc.
PIS89000
In Commercial Distribution

  • M269PIS890001 ()
  • 10381780237150 ()

  • 3.907 in L x 3.865 in W


  • Surgical implant template, reusable

Integra® PyroSphere® - 10381780237044

PCS Implant Extractor used to remove implants.
Ascension Orthopedics, Inc.
EXT43001
In Commercial Distribution

  • M269EXT430011 ()
  • 10381780237044 ()

  • 7.9 in L x 3.1 in W
EXT-430-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra® - 10381780237037

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005621
In Commercial Distribution

  • M269TRL90056211 ()
  • 10381780237037 ()

  • 2.245 in dia x .825 in H
TRL-900-56/21

  • Humeral head prosthesis trial, reusable

Integra® - 10381780237020

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005221
In Commercial Distribution

  • M269TRL90052211 ()
  • 10381780237020 ()

  • 2.047 in dia x .825 in H
TRL-900-52/21

  • Humeral head prosthesis trial, reusable

Integra® - 10381780237013

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9005218
In Commercial Distribution

  • M269TRL90052181 ()
  • 10381780237013 ()

  • 2.047 in dia x .707 in H
TRL-900-52/18

  • Humeral head prosthesis trial, reusable

Integra® - 10381780237006

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9004820
In Commercial Distribution

  • M269TRL90048201 ()
  • 10381780237006 ()

  • 1.89 in dia x .785 in H
TRL-900-48/20

  • Humeral head prosthesis trial, reusable

Integra® - 10381780236993

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
TRL9004817
In Commercial Distribution

  • M269TRL90048171 ()
  • 10381780236993 ()

  • 1.89 in dia x .667 in H
TRL-900-48/17

  • Humeral head prosthesis trial, reusable
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