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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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The Eccentric Head Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0923-010-3814E
In Commercial Distribution

  • M269TRL09230103814E1 ()
  • 10381780235552 ()

  • 1.5 in dia x .551 in H
TRL-0923-010-3814E

  • Humeral head prosthesis trial, reusable
Surgical Instruments Starter Awl
Ascension Orthopedics, Inc.
AWL10001
In Commercial Distribution

  • M269AWL100011 ()
  • 10381780242154 ()

  • 3.26 in L x .118 in dia
AWL-100-01

  • Orthopaedic knife
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.
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
Movement® Great Toe System The sizer alignment guide is used with the Movement Great Toe system.
Ascension Orthopedics, Inc.
ALG-890-00
In Commercial Distribution

  • M269ALG890001 ()
  • 10381780242048 ()

  • 3.25 in L x .13 in dia
ALG89000

  • Orthopaedic implant aiming arm
Surgical Instruments Alignment Guide
Ascension Orthopedics, Inc.
ALG10000
In Commercial Distribution

  • M269ALG100001 ()
  • 10381780242031 ()

  • 4.5 in L; 3.25 in L rod
ALG-100-00

  • Orthopaedic implant aiming arm
Integra® External Fixation System The punch is used for the half pin drill guide in the external fixation system.
Ascension Orthopedics, Inc.
12225020002
In Commercial Distribution

  • M269122250200021 ()
  • 10381780248187 ()

  • 5.245 in L x .176 in dia
12225020002

  • Surgical drill guide, reusable
Integra® External Fixation System The generic lid is the top part of the case which locks onto the base and keeps content inside.
Ascension Orthopedics, Inc.
12227006
In Commercial Distribution

  • M269122270061 ()
  • 10381780247999 ()

  • 21.61 in L x 11.10 in W
12227006

  • Instrument tray, reusable
Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-1006-05
Not in Commercial Distribution

  • M269CSA1006051 ()
  • 10381780247968 ()

  • 6.584 in L x 3.19 in W
CSA100605

  • Instrument tray, reusable
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