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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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OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Ossdsign AB
14 mm, 6 fixation-points
Not in Commercial Distribution

  • 17350086550235 ()
  • 07350086550238 ()
  • 27350086550232 ()

  • 6 fixation-points
  • Outer Diameter: 14 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Ossdsign AB
14 mm, 2 fixation-points
Not in Commercial Distribution

  • 07350086550221 ()
  • 17350086550228 ()
  • 27350086550225 ()

  • 2 fixation-points
  • Outer Diameter: 14 Millimeter
n/a

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Implant Driver 4.5/5.0 Long
Dentsply Implants Manufacturing GmbH
25012
In Commercial Distribution

  • 07392532119316 ()
25012

  • Surgical screwdriver, reusable
Implant Driver 4.5/5.0 Short
Dentsply Implants Manufacturing GmbH
25011
In Commercial Distribution

  • 07392532119309 ()
25011

  • Surgical screwdriver, reusable
Implant Driver 3.5/4.0 Long
Dentsply Implants Manufacturing GmbH
25010
In Commercial Distribution

  • 07392532119293 ()
25010

  • Surgical screwdriver, reusable
Implant Driver 3.5/4.0 Short
Dentsply Implants Manufacturing GmbH
25009
In Commercial Distribution

  • 07392532119286 ()
25009

  • Surgical screwdriver, reusable
Implant Driver 3.0 Long
Dentsply Implants Manufacturing GmbH
25008
In Commercial Distribution

  • 07392532119279 ()
25008

  • Surgical screwdriver, reusable
Implant Driver 3.0 Short
Dentsply Implants Manufacturing GmbH
25007
In Commercial Distribution

  • 07392532119262 ()
25007

  • Surgical screwdriver, reusable
Removal Tool M1.4, Long
Dentsply Implants Manufacturing GmbH
24037
In Commercial Distribution

  • 07392532078217 ()
24037

  • Surgical screwdriver, reusable
Removal Tool M1.4, Short
Dentsply Implants Manufacturing GmbH
24021
In Commercial Distribution

  • 07392532078200 ()
24021

  • Surgical screwdriver, reusable
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