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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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Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285210SND
In Commercial Distribution

  • 10381780048787 ()
  • M248285210SND1 ()

  • 2.7mm diam. x 10mm length
285210SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285124SND
In Commercial Distribution

  • 10381780048770 ()
  • M248285124SND1 ()

  • 3.0mm diam. x 24mm length
285124SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285122SND
In Commercial Distribution

  • 10381780048763 ()
  • M248285122SND1 ()

  • 3.0mm diam. x 22mm length
285122SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285120SND
In Commercial Distribution

  • 10381780048756 ()
  • M248285120SND1 ()

  • 3.0mm diam. x 20mm length
285120SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285118SND
In Commercial Distribution

  • M248285118SND1 ()
  • 10381780048749 ()

  • 3.0mm diam. x 18mm length
285118SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285116SND
In Commercial Distribution

  • M248285116SND1 ()
  • 10381780048732 ()

  • 3.0mm diam. x 16mm length
285116SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285114SND
In Commercial Distribution

  • 10381780048725 ()
  • M248285114SND1 ()

  • 3.0mm diam. x 14mm length
285114SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285112SND
In Commercial Distribution

  • 10381780048718 ()
  • M248285112SND1 ()

  • 3.0mm diam. x 12mm length
285112SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
Titanium alloy Newdeal sterile locking system fixation consists of screws and washers. This system is available in different sizes. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
NEWDEAL
285110SND
In Commercial Distribution

  • 10381780048701 ()
  • M248285110SND1 ()

  • 3.0mm diam. x 10mm length
285110SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The proposed device, the XPress BCD, is used in conjunction stereotactic breast biopsy devices. The primary function of the device is to provide effective consistent mechanical breast compression following stereotactic-guided biopsy, replacing standard manual compression of post breast biopsy sites. Reliable and effective mechanical breast compression, with equivalent clinical outcomes, reduces medical staff blood exposure and allows for significant labor savings.
COMPOSITE MANUFACTURING, INC.
BCD-001
In Commercial Distribution

  • 00810105030501 ()


  • Mammographic x-ray system compression paddle
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