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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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Titan™ Total Shoulder System The stand is used as a base during stem impaction.
Ascension Orthopedics, Inc.
SS0920054001
In Commercial Distribution

  • M269SIS09200540011 ()
  • 10381780247456 ()

  • 4.0 in L x 2.50 in W x 1.0 in H
SIS-0920-054-001

  • Surgical implant/trial-implant/sizer holder, reusable
Titan™ Total Shoulder System The version rod is used in the total shoulder system.
Ascension Orthopedics, Inc.
SET189D007
In Commercial Distribution

  • M269SET189D0071 ()
  • 10381780247449 ()

  • 6.0 in L x .095 in W
SET189-D007

  • Orthopaedic implant/instrument assembling device
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
The Fin-Lock Glenoid Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0926-030-02A
In Commercial Distribution

  • M269TRL092603002A1 ()
  • 10381780258643 ()

  • Medium


  • Shoulder glenoid fossa prosthesis trial
The Fin-Lock Glenoid Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL-0926-030-00A
In Commercial Distribution

  • M269TRL092603000A1 ()
  • 10381780258629 ()

  • X-Small


  • Shoulder glenoid fossa prosthesis trial
The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
INVUITY, INC.
1.5 x 10 x 15 in
In Commercial Distribution

  • 00816728020295 ()

  • Length: 15 Inch
  • Width: 10 Inch
  • Height: 1.5 Inch
11185

  • Device sterilization/disinfection container, reusable
The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
INVUITY, INC.
1.5 x 6 x 10 in
In Commercial Distribution

  • 00816728020288 ()

  • Length: 10 Inch
  • Width: 6 Inch
  • Height: 1.5 Inch
11070

  • Device sterilization/disinfection container, reusable
The Invuity® Sterilization Tray is intended to allow sterilization of the enclosed medical devices.
INVUITY, INC.
Small
In Commercial Distribution

  • 00816728020264 ()

  • Length: 10 Inch
  • Width: 6 Inch
  • Height: 1.5 Inch
110200

  • Device sterilization/disinfection container, reusable
Integra® Jarit® Cooley Suction Tube, 12-1/4", Intracardiac Tip Is Detachable, 10mm Wide
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
310108
In Commercial Distribution

  • M2743101081 ()
  • 10381780130895 ()
310-108

  • Suction system catheter, general-purpose
The Fracture Body Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
T95002008STD
In Commercial Distribution

  • M269TRL095002008STD1 ()
  • 10381780124238 ()

  • 08 Standard


  • Humeral body prosthesis trial
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