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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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#710 IMPLANT INSTRUMENT, #6 Handle
HU-FRIEDY MFG. CO., LLC
IMP63456
In Commercial Distribution

  • 10889950072995 ()
IMP63456

  • Dental implant system
INFINITY 14 DD BLUE,DUAL GRIT STONE CLIP
HU-FRIEDY MFG. CO., LLC
IMN9148ADG
In Commercial Distribution

  • 10889950070199 ()


  • Device sterilization/disinfection container, reusable
INFINI 14 DD PURPLE,DUAL GRIT STONE CLIP
HU-FRIEDY MFG. CO., LLC
IMN9144ADG
In Commercial Distribution

  • 10889950069995 ()


  • Device sterilization/disinfection container, reusable
The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play. The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system. The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller.
NORTH AMERICAN RESCUE, LLC
63-5901
In Commercial Distribution

  • 00868058000447 ()
35-0003

  • Conduction blood/fluid warmer
No Description
Biomet Orthopedics, LLC
US32-420063
In Commercial Distribution

  • 00880304181229 ()
US32-420063

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
US32-420062
In Commercial Distribution

  • 00880304181212 ()
US32-420062

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
S993136
In Commercial Distribution

  • 00880304171633 ()

  • 36MM
S993136

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
S663136
In Commercial Distribution

  • 00880304168503 ()
S663136

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
S333136
In Commercial Distribution

  • 00880304165526 ()

  • 36MM
S333136

  • Knee femur prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
S123136
In Commercial Distribution

  • 00880304163706 ()

  • 36MM
S123136

  • Femoral head prosthesis trial
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