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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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A rongeur is used in oral surgery to remove bony fragments or soft tissue
Suncoast Dental, Inc
Rongeurs
In Commercial Distribution

  • 00083208130267 ()
Rongeurs

  • Dental rongeur
K11 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
MECTRON SPA
K11
In Commercial Distribution

  • E322029001700010 ()
02900170-001

  • Ultrasonic surgical system torque wrench, reusable
K10 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
MECTRON SPA
K10
In Commercial Distribution

  • E32202900137 ()
  • E322029001370010 ()
02900137-001

  • Ultrasonic surgical system torque wrench, reusable
K8 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
MECTRON SPA
K8
In Commercial Distribution

  • E322029001090010 ()
02900109-001

  • Ultrasonic surgical system torque wrench, reusable
K7 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
MECTRON SPA
K7
In Commercial Distribution

  • E322029000810010 ()
02900081-001

  • Ultrasonic surgical system torque wrench, reusable
K6 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
MECTRON SPA
K6
In Commercial Distribution

  • E322029000740010 ()
02900074-001

  • Ultrasonic surgical system torque wrench, reusable
Integra® TruArch® The TruArch removal driver is used to remove the implant.
Ascension Orthopedics, Inc.
TA-3115
In Commercial Distribution

  • M269TA31151 ()
  • 10381780247531 ()

  • 165.1 mm L x 5 mm dia
TA-3115

  • Surgical screwdriver, reusable
Titan™ Total Shoulder System The handle is used with the head cutting template.
Ascension Orthopedics, Inc.
ROD-0923-040-001
In Commercial Distribution

  • M269ROD09230400011 ()
  • 10381780247302 ()

  • 6.23 in L x .19 in dia
ROD-0923-040-001

  • Surgical instrument handle, non-torque-limiting
Titan™ Total Shoulder System The handle is used with the head cutting template.
Ascension Orthopedics, Inc.
RD0920040002
In Commercial Distribution

  • M269ROD09200400021 ()
  • 10381780247296 ()

  • 6.23 in L x .19 in dia
ROD-0920-040-002

  • Surgical instrument handle, non-torque-limiting
Integra® Total Foot System The Rearfoot Distraction Gauge is used to assess size.
Ascension Orthopedics, Inc.
RDGTFS01
In Commercial Distribution

  • M269RDGTFS011 ()
  • 10381780246770 ()

  • 50 mm L
RDG-TFS-01

  • Surgical depth gauge, reusable
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