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 Class Implantable

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SCHANZ SCREW RAPID DRIVER FOR MANDIBLE EXTERNAL FIXATOR II
Synthes GmbH
03.305.024
In Commercial Distribution

  • H980033050240 ()
  • 10887587010007 ()
03305024

  • Manual surgical rotary handpiece, reusable
ROD TEMPLATE FOR 4.0MM RODS FOR MANDIBLE EXTERNAL FIXATOR
Synthes GmbH
03.305.009
In Commercial Distribution

  • 07611819881051 ()
  • H980033050090 ()
  • 10887587009964 ()
03305009

  • Surgical implant template, reusable
TI SLF-DRLG MOUNTING PIN 50MM F/EXTERNAL MIDFACE DISTRACTOR
Synthes GmbH
390.128
In Commercial Distribution

  • H9803901280 ()
  • 10887587040936 ()
390128

  • Implantable craniofacial bone distractor
LID FOR MANDIBLE EXTERNAL FIXATOR II SET GRAPHIC CASE
Synthes GmbH
306.721
In Commercial Distribution

  • 07611819895157 ()
  • H9803067210 ()
  • 10887587034218 ()
306721

  • Surgical instrument/implant rack
TI SLF-DRLG MOUNTING PIN 40MM F/EXTERNAL MIDFACE DISTRACTOR
Synthes GmbH
390.126
In Commercial Distribution

  • H9803901260 ()
  • 10887587040929 ()
390126

  • Implantable craniofacial bone distractor
BASE FOR MANDIBLE EXTERNAL FIXATOR II SET GRAPHIC CASE
Synthes GmbH
306.720
In Commercial Distribution

  • 07611819895140 ()
  • H9803067200 ()
  • 10887587034201 ()
306720

  • Surgical instrument/implant rack
REPLACEMENT BRACKETS (3) F/LRG EXTERNAL FIXATOR GRAPHIC CASE
Synthes GmbH
690.315.14
In Commercial Distribution

  • H679690315140 ()
  • 10886982252142 ()
69031514

  • Surgical instrument/implant rack
WRIST COVER
Synthes GmbH
394.052
In Commercial Distribution

  • H6793940520 ()
  • 10886982199461 ()
394052

  • Limb-worn device hygienic cover
MAXFRAME(TM) RETENTION BAND
Synthes GmbH
03.313.886
In Commercial Distribution

  • 10886982306487 ()
03313886

  • External orthopaedic fixation system, single-use
MAXFRAME(TM) SLOTTED WASHER
Synthes GmbH
03.313.868
In Commercial Distribution

  • 10886982306456 ()
03313868

  • External orthopaedic fixation system, single-use
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