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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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iSy Handle for iSy Gingiva former, long
ALTATEC GmbH
P5300.6050
In Commercial Distribution

  • E219P530060501 ()
  • E219P53006050150 ()
P5300.6050

  • Surgical screwdriver, reusable
iSy Implant insertion tool, long
ALTATEC GmbH
P5300.6032
In Commercial Distribution

  • E219P530060321 ()
  • E219P53006032150 ()
P5300.6032

  • Surgical screwdriver, reusable
iSy Implant insertion tool, extra short
ALTATEC GmbH
P5300.6028
In Commercial Distribution

  • E219P530060281 ()
  • E219P53006028150 ()
P5300.6028

  • Surgical screwdriver, reusable
Adapter for screw implants, short, for CAMLOG® SCREW-LINE implants Ø 3.3 mm
ALTATEC GmbH
K5302.3311
In Commercial Distribution

  • E219K530233111 ()
K5302.3311

  • Surgical screwdriver, reusable
Adapter for screw implants, long, for CAMLOG® SCREW-LINE implants Ø 3.3 mm
ALTATEC GmbH
K5302.3310
In Commercial Distribution

  • E219K530233101 ()
  • E219K90473300150 ()
K5302.3310

  • Surgical screwdriver, reusable
Symbios BoneShield rectangular 33x25 mm
Dentsply Implants Manufacturing GmbH
32597402
In Commercial Distribution

32597402

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Symbios BoneShield oval 20x15 mm
Dentsply Implants Manufacturing GmbH
32597400
In Commercial Distribution

32597400

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
The sterile 2' in 1' cannulated shouldered drill, with a 4.0mm diameter cilyndrical attachment and a total length of 65mm, a four lip 3mm diameter countersink, is designed to drill in one single drive the body of the 3.0 & 3.7mm compression screws and the shape of the screw heads to allow complete countersink.
NEWDEAL
119023SND
In Commercial Distribution

  • M248119023SND1 ()
  • 10381780053514 ()

  • 1.2mm inner/2.2mm outer diameter X 28mm length


  • Cannulated surgical drill bit, single-use
The SURFIX® hexagonal screwdriver is used to mill the bone to introduce the collar of the screw and to screw screws and lock screws. It is also used to remove screws and lock screws.
NEWDEAL
MA004ND
In Commercial Distribution

  • M248MA004ND1 ()
  • 10381780052357 ()

  • 3.49mm 6 pans; 215mm total length


  • Surgical screwdriver, reusable
The hexagonal screwdriver is used to implant or explant screws.
NEWDEAL
519295ND
In Commercial Distribution

  • M248519295ND1 ()
  • 10381780052340 ()

  • 3.49mm 6 pans; 300mm total length


  • Surgical screwdriver, reusable
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