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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DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-491-61-01
Not in Commercial Distribution

  • 00888118108661 ()

  • 20 MM, 16 HOLE


  • Implantable craniofacial bone distractor
ACT WRENCH, ARTICULATING, PATIENT, RAPID PALATABLE EXPANDER 2
KLS-Martin L.P.
51-567-95-07
In Commercial Distribution

  • 00888118107855 ()

  • 6 MM


  • Implantable craniofacial bone distractor expansion tool, home-use
TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, RIGHT, TI-6AL-4V
KLS-Martin L.P.
99-488-08-04
In Commercial Distribution

  • 00888118106056 ()

  • 26 MM


  • Implantable craniofacial bone distractor
TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, LEFT, TI-6AL-4V
KLS-Martin L.P.
99-488-08-02
In Commercial Distribution

  • 00888118106032 ()

  • 26 MM


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, WILLIAMS, END DRV, OPP RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-475-20-01
In Commercial Distribution

  • 00888118100689 ()

  • 30 MM, 24 HOLE


  • Implantable craniofacial bone distractor
DIST, SYMPHYSIS, ZURICH 1, ROTTERDAM, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-509-10-09
In Commercial Distribution

  • 00888118099754 ()

  • 10 MM, 8 HOLE


  • Implantable craniofacial bone distractor
DIST, SYMPHYSIS, ZURICH 1, BOLOGNA, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-508-10-09
In Commercial Distribution

  • 00888118099730 ()

  • 10 MM, 10 HOLE


  • Implantable craniofacial bone distractor
PLATE, RAMUS TRANS, MANDIBLE, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-477-21-01
In Commercial Distribution

  • 00888118099716 ()

  • 10 HOLE MESH


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, GENIOPLASTY, RIGHT, CCW ACT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-907-97-09
Not in Commercial Distribution

  • 00888118099693 ()

  • 20 MM, 44 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, ZURICH 2, GENIOPLASTY, LEFT, CCW ACT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
00-907-96-09
Not in Commercial Distribution

  • 00888118099686 ()

  • 20 MM, 44 HOLE


  • Implantable craniofacial bone distractor
No Description
KLS-Martin L.P.
51-524-25-09
Not in Commercial Distribution

  • 00888118099679 ()

  • 15 MM, 18 HOLE


  • Implantable craniofacial bone distractor
DIST, RAPID PALATAL EXPANDER, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-565-36-09
Not in Commercial Distribution

  • 00888118099662 ()

  • 36 MM, 2 HOLE


  • Implantable craniofacial bone distractor
DIST, RAPID PALATAL EXPANDER, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-565-27-09
Not in Commercial Distribution

  • 00888118099655 ()

  • 27 MM, 2 HOLE


  • Implantable craniofacial bone distractor
DIST, RAPID PALATAL EXPANDER, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-565-18-09
Not in Commercial Distribution

  • 00888118099648 ()

  • 18 MM, 2 HOLE


  • Implantable craniofacial bone distractor
DIST, RAPID PALATAL EXPANDER, 2.0-2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-565-09-09
Not in Commercial Distribution

  • 00888118099631 ()

  • 9 MM, 2 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-526-30-09
In Commercial Distribution

  • 00888118099617 ()

  • 30 MM, 32 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-411-30-09
In Commercial Distribution

  • 00888118098610 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, BI LEVEL MIDFACE, ADJ, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-410-30-09
In Commercial Distribution

  • 00888118098603 ()

  • 30 MM, 35 HOLE


  • Implantable craniofacial bone distractor
TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, TI-6AL-4V
KLS-Martin L.P.
99-474-84-05
In Commercial Distribution

  • 00888118098009 ()

  • 16 MM


  • Implantable craniofacial bone distractor
PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 6 MM AP, 3 MM BRG, TI-6AL-4V
KLS-Martin L.P.
99-474-84-02
In Commercial Distribution

  • 00888118097972 ()

  • 9 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.
99-474-84-01
In Commercial Distribution

  • 00888118097965 ()

  • 30 MM, 28 HOLE


  • Implantable craniofacial bone distractor
DIST, MANDIBLE, HYPERDRIVE MICRO, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-066-18-01
In Commercial Distribution

  • 00888118097958 ()

  • 30 MM, 24 HOLE


  • Implantable craniofacial bone distractor
DIST, LEFORT 3/MONO, KAWAMOTO, URATA, CVD, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-543-30-09
In Commercial Distribution

  • 00888118096920 ()

  • 30 MM, 36 HOLE, 4 X 4 MESH


  • Implantable craniofacial bone distractor
No Description
I3 IMPLANT LLC
I3PHB
In Commercial Distribution

  • 00810027862471 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3NONH
In Commercial Distribution

  • 00810027862464 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3PH
In Commercial Distribution

  • 00810027862457 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3ANTSMU
In Commercial Distribution

  • 00810027862440 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3ANTRMU
In Commercial Distribution

  • 00810027862433 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3ANAMU
In Commercial Distribution

  • 00810027862426 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3ANFSMU
In Commercial Distribution

  • 00810027862419 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU303M
In Commercial Distribution

  • 00810027862402 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU302M
In Commercial Distribution

  • 00810027862396 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU301M
In Commercial Distribution

  • 00810027862389 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU173M
In Commercial Distribution

  • 00810027862372 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU172M
In Commercial Distribution

  • 00810027862365 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU171M
In Commercial Distribution

  • 00810027862358 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3TRMU
In Commercial Distribution

  • 00810027862341 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3AMU
In Commercial Distribution

  • 00810027862334 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3TSMU
In Commercial Distribution

  • 00810027862327 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3FSMU
In Commercial Distribution

  • 00810027862310 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU04
In Commercial Distribution

  • 00810027862303 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU03
In Commercial Distribution

  • 00810027862297 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU02
In Commercial Distribution

  • 00810027862280 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3MU01
In Commercial Distribution

  • 00810027862273 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3TAE
In Commercial Distribution

  • 00810027862266 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3WAN
In Commercial Distribution

  • 00810027862259 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3AN
In Commercial Distribution

  • 00810027862242 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3CCTL
In Commercial Distribution

  • 00810027862235 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3WOP
In Commercial Distribution

  • 00810027862228 ()


  • Dental implant suprastructure, temporary, custom-made
No Description
I3 IMPLANT LLC
I3OT
In Commercial Distribution

  • 00810027862211 ()


  • Dental implant suprastructure, temporary, custom-made
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