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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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COPELAND SHOULDER SYSTEM - 00880304204638

No Description
Biomet Orthopedics, LLC
11-114625
In Commercial Distribution

  • 00880304204638 ()

  • SIZE 5
11-114625

  • Coated shoulder humeral stem prosthesis

STANMORE HIP SYSTEM - 00880304257283

No Description
Biomet Orthopedics, LLC
164240
In Commercial Distribution

  • 00880304257283 ()

  • 5 SIZE
164240

  • Orthopaedic cement spacer

VuMesh™ - 10889981036614

14mm Sq 5 Deg End Cap
Seaspine Orthopedics Corporation
15-12-1450
In Commercial Distribution

  • 10889981036614 ()

  • 14mm 5
15-12-1450

  • Vertebral body prosthesis, non-sterile

VuMesh™ - 10889981036577

12mm Sq 5 Deg End Cap
Seaspine Orthopedics Corporation
15-12-1250
In Commercial Distribution

  • 10889981036577 ()

  • 12mm 5
15-12-1250

  • Vertebral body prosthesis, non-sterile

CliXdish™ - D0026930061

CliXdish™ Mixing Well Refill
DENTSPLY INTERNATIONAL INC.
693006
Not in Commercial Distribution

  • D0026930060 ()
  • D0026930061 ()

  • 5 CliXdishes
693006

  • Dappen dish, reusable

Paragon - 09340499024769

Paragon Distal Broach Size 5 - Male (Omni)
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GM08001-349-05
In Commercial Distribution

  • 09340499024769 ()

  • Size 5
GM08001-349-05

  • Orthopaedic broach

GRU Femur - 09340499005546

GRU Femur RMLL Size 5
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GRU-RM/LL-5F-C
Not in Commercial Distribution

  • 09340499005546 ()

  • Size 5
GRU-RM/LL-5F-C

  • Uncoated unicondylar knee femur prosthesis

GRU Tibia - 09340499005423

GRU Tibia Size 5 9.5mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GRU-5T-9.5-P-R
Not in Commercial Distribution

  • 09340499005423 ()

  • Size 5
GRU-5T-9.5-P-R

  • Uncoated unicondylar knee tibia prosthesis, polyethylene

GRU Tibia - 09340499005416

GRU Tibia Size 5 8.5mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GRU-5T-8.5-P-R
Not in Commercial Distribution

  • 09340499005416 ()

  • Size 5
GRU-5T-8.5-P-R

  • Uncoated unicondylar knee tibia prosthesis, polyethylene

GRU Tibia - 09340499005409

GRU Tibia Size 5 7.5mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GRU-5T-7.5-P-R
Not in Commercial Distribution

  • 09340499005409 ()

  • Size 5
GRU-5T-7.5-P-R

  • Uncoated unicondylar knee tibia prosthesis, polyethylene
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