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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PLATE, RED 2, MIDFACE FIXATION, CP TITANIUM
KLS-Martin L.P.
01-581-02-04
Not in Commercial Distribution

  • 00888118032959 ()

  • T=1.0 MM


  • Implantable craniofacial bone distractor
PLATE, LEFORT 3/MONO, DETACH, FOR 00-909-73, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-80-09
Not in Commercial Distribution

  • 00888118032416 ()

  • 2 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, CVD, DETACH BODY, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-73-09
Not in Commercial Distribution

  • 00888118032409 ()

  • 30 MM, 20 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, MICRO ZURICH 2, END DRV, TOP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-65-09
Not in Commercial Distribution

  • 00888118032393 ()

  • 20 MM, 36 HOLE


  • Implantable craniofacial bone distractor
DIST, CRANIAL, MICRO ZURICH 2, ARNAUD- MARCHAC, END DRV, 1.5-1.8MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-55-09
Not in Commercial Distribution

  • 00888118032386 ()

  • 20 MM, 8 HOLE


  • Implantable craniofacial bone distractor
DIST, PALATAL, ROTTERDAM, NON SYNDROMIC, X PLATES, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-20-09
Not in Commercial Distribution

  • 00888118032379 ()

  • 19 MM, 56 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, CVD, RIGHT, SWIVEL, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-15-09
Not in Commercial Distribution

  • 00888118032362 ()

  • 30 MM, 10 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, CVD, LEFT, SWIVEL, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-14-09
Not in Commercial Distribution

  • 00888118032355 ()

  • 30 MM, 10 HOLE


  • Implantable craniofacial bone distractor
PLATE, 3DX, MANDIBULAR FIXATION, CP TITANIUM
KLS-Martin L.P.
00-909-08-09
Not in Commercial Distribution

  • 00888118032348 ()

  • 3 HOLE, 2 PIN HOLE


  • Implantable craniofacial bone distractor
DIST, PALATAL, ROTTERDAM, SYNDROMIC, STR PLATES, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-909-06-09
Not in Commercial Distribution

  • 00888118032164 ()

  • 19 MM, 12 HOLE


  • Implantable craniofacial bone distractor
ACT ARM, FLEXIBLE, TI-6AL-4V
KLS-Martin L.P.
00-909-02-09
Not in Commercial Distribution

  • 00888118032157 ()

  • 50 MM


  • Implantable craniofacial bone distractor
ACT ARM, FLEXIBLE, TI-6AL-4V
KLS-Martin L.P.
00-909-01-09
Not in Commercial Distribution

  • 00888118032140 ()

  • 40 MM


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, CVD, EXTENDED ARM, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-908-06-09
Not in Commercial Distribution

  • 00888118032133 ()

  • 30 MM, 22 HOLE


  • Implantable craniofacial bone distractor
DIST, SYMPHYSIS, ZURICH 2, 45* ANGLE ACT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-907-78-09
Not in Commercial Distribution

  • 00888118032126 ()

  • 15 MM, 26 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, WILLIAMS, MID DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-907-55-09
Not in Commercial Distribution

  • 00888118032102 ()

  • 25 MM, 24 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, RIGHT ANGLE, RIGHT, TI-6AL-4V
KLS-Martin L.P.
00-907-17-09
Not in Commercial Distribution

  • 00888118032096 ()

  • 30 MM, 24 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, RIGHT ANGLE, LEFT, TI-6AL-4V
KLS-Martin L.P.
00-907-16-09
Not in Commercial Distribution

  • 00888118032089 ()

  • 30 MM, 24 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, RIGHT ANGLE, RIGHT, TI-6AL-4V
KLS-Martin L.P.
00-907-13-09
Not in Commercial Distribution

  • 00888118032072 ()

  • 20 MM, 24 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, WILLIAMS, END DRV, DETACH PLATES, TI-6AL-4V
KLS-Martin L.P.
00-907-00-09
Not in Commercial Distribution

  • 00888118032065 ()

  • 40 MM


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, CVD, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-906-87-09
Not in Commercial Distribution

  • 00888118032058 ()

  • 30 MM, 22 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, MICRO ZURICH 2, END DRV, SQUARE MESH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
02-300-20-09
Not in Commercial Distribution

  • 00888118069344 ()

  • 20 MM, 36 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, MICRO ZURICH 2, END DRV, SQUARE MESH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
02-300-15-09
Not in Commercial Distribution

  • 00888118066374 ()

  • 15 MM, 36 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, ZURICH TELE, ADJ, MIDFACE, CONE CONNECT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-362-20-09
In Commercial Distribution

  • 00888118143457 ()

  • 20 MM, 28 HOLE


  • Implantable craniofacial bone distractor
LID, BASE, CRANIOXPAND
KLS-Martin L.P.
CTM-2303-105
In Commercial Distribution

  • 00888118142986 ()


  • Surgical instrument/implant rack
BASE, CRANIOXPAND
KLS-Martin L.P.
CTM-2303-100
In Commercial Distribution

  • 00888118142979 ()


  • Surgical instrument/implant rack
No Description
KLS-Martin L.P.
99-565-44-05
Not in Commercial Distribution

  • 00888118116321 ()

  • 59 MM


  • Hand-held dental retractor
DIST, LEFORT 1, HYPERDRIVE, RIGHT, RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-476-72-02
In Commercial Distribution

  • 00888118115447 ()

  • 30 MM, 29 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, HYPERDRIVE, LEFT, RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-476-72-01
In Commercial Distribution

  • 00888118115430 ()

  • 30 MM, 29 HOLE


  • Implantable craniofacial bone distractor
PLATE, MODULAR, CRANIAL, NON SLIDING, 3 MM HOOKS, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
99-461-66-05
In Commercial Distribution

  • 00888118113788 ()

  • 8 HOLE


  • Implantable craniofacial bone distractor
PLATE, MODULAR, CRANIAL, SLIDING, 3 MM HOOKS, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
99-461-66-04
In Commercial Distribution

  • 00888118113771 ()

  • 8 HOLE


  • Implantable craniofacial bone distractor
PLATE, MODULAR, CRANIAL, NON SLIDING, 1.5-1.8 MM SCREW, CP TITANIUM
KLS-Martin L.P.
99-461-66-03
In Commercial Distribution

  • 00888118113764 ()

  • 8 HOLE


  • Implantable craniofacial bone distractor
DIST, ZURICH 2, MODULAR, END DRV, BODY ONLY, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-461-66-01
In Commercial Distribution

  • 00888118113740 ()

  • 30 MM


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, ZURICH 2, RIGHT, RTCH, 4 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-491-64-02
In Commercial Distribution

  • 00888118113504 ()

  • 20 MM, 19 HOLE, T= 1.0 MM


  • Implantable craniofacial bone distractor
DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, 4 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-491-64-01
In Commercial Distribution

  • 00888118113498 ()

  • 20 MM, 19 HOLE, T= 1.0 MM


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, MICRO ZURICH 2, LYPKA, END DRV, 65*, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-486-14-01
In Commercial Distribution

  • 00888118108036 ()

  • 30 MM, 54 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, LEFT, BODY ONLY, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-490-78-02
In Commercial Distribution

  • 00888118106346 ()

  • 25 MM


  • Implantable craniofacial bone distractor
TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, RIGHT, TI-6AL-4V
KLS-Martin L.P.
99-488-08-03
In Commercial Distribution

  • 00888118106049 ()

  • 18 MM


  • Implantable craniofacial bone distractor
TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, LEFT, TI-6AL-4V
KLS-Martin L.P.
99-488-08-01
In Commercial Distribution

  • 00888118106025 ()

  • 18 MM


  • Implantable craniofacial bone distractor
DIST, PALATAL, ZURICH 2, TRANS, TLTS, RIGHT ANGLE, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-477-33-01
In Commercial Distribution

  • 00888118103987 ()

  • 20 MM, 144 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, M3, CVD, RIGHT, RTCH, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-479-81-02
In Commercial Distribution

  • 00888118103949 ()

  • 30 MM, 6 MM HOOK, 46-52 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, M3, CVD, LEFT, RTCH, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-479-81-01
In Commercial Distribution

  • 00888118103932 ()

  • 30 MM, 6 MM HOOK, 46-52 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, HYPERDRIVE MICRO, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-528-30-09
In Commercial Distribution

  • 00888118103925 ()

  • 30 MM, 24 HOLE


  • Implantable craniofacial bone distractor
PATIENT SCREWDRIVER, HEX, ZURICH, 1.0 MM PER TURN, GOLD
KLS-Martin L.P.
51-510-90-07
In Commercial Distribution

  • 00888118103741 ()

  • 2.5 MM HEX


  • Implantable craniofacial bone distractor expansion tool, home-use
PATIENT SCREWDRIVER, HEX, ZURICH, 0.25 MM PER TURN, BLACK
KLS-Martin L.P.
26-750-25-07
In Commercial Distribution

  • 00888118103109 ()

  • 2.0 MM HEX


  • Implantable craniofacial bone distractor expansion tool, home-use
No Description
KLS-Martin L.P.
990-5966-01
Not in Commercial Distribution

  • 00888118102225 ()


  • Implantable craniofacial bone distractor
DIST, CRANIAL, ZURICH 1, MID DRV, DETACH PLATES, MIDLINE, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-474-02-01
In Commercial Distribution

  • 00888118102119 ()

  • 30 MM, 12 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, MICRO ZURICH 2, END DRV, RIGHT, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-432-20-09
Not in Commercial Distribution

  • 00888118102003 ()

  • 20 MM, 18 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, MICRO ZURICH 2, END DRV, LEFT, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-431-20-09
Not in Commercial Distribution

  • 00888118101990 ()

  • 20 MM, 18 HOLE


  • Implantable craniofacial bone distractor
DIST, RPE, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-567-09-09
In Commercial Distribution

  • 00888118101952 ()

  • SIZE 1, 9 MM, 2 HOLE


  • Implantable craniofacial bone distractor
DIST, RPE, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-567-27-09
In Commercial Distribution

  • 00888118101945 ()

  • SIZE 3, 27 MM, 2 HOLE


  • Implantable craniofacial bone distractor
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