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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Patient specific, 3D printed, single use surgical marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic.
Mirrorme3d, LLC
MOST
In Commercial Distribution



  • Custom-made orthopaedic/craniofacial surgical guide
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0664
In Commercial Distribution

  • 09348215081676 ()
  • 09348215113810 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0663
In Commercial Distribution

  • 09348215081669 ()
  • 09348215113803 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0662
In Commercial Distribution

  • 09348215081652 ()
  • 09348215113797 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0661
In Commercial Distribution

  • 09348215080884 ()
  • 09348215113780 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0660
In Commercial Distribution

  • 09348215080877 ()
  • 09348215113773 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0659
In Commercial Distribution

  • 09348215080860 ()
  • 09348215105372 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0666
In Commercial Distribution

  • 09348215081690 ()
  • 09348215080938 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-35-0665
In Commercial Distribution

  • 09348215081683 ()
  • 09348215080921 ()


  • Surgical implant template, reusable
COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
Heraeus Medical GmbH
S
In Commercial Distribution

  • 04260102139398 ()
  • 04260102139381 ()
  • 04260102139404 ()
5159874

  • Knee revision prosthesis trial
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