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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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Valkyrie Thoracic Fixation System - 00810071390647

Driver Bit
J.M. Longyear Manufacturing, LLC
01-01-3035
In Commercial Distribution

  • 00810071390647 ()
01-01-3035

  • Surgical screwdriver, single-use

Cannulated Screw System + - 00810040683596

7.5 CANN DRILL BIT LARGE QC/LONG - STER
Tyber Medical LLC
03.333.113S
In Commercial Distribution

  • 00810040683596 ()
03.333.113S

  • Cannulated surgical drill bit, single-use

Cannulated Screw System + - 00810040682018

5.0 CANN DRILL BIT LARGE QC/LONG - STER
Tyber Medical LLC
03.333.112S
In Commercial Distribution

  • 00810040682018 ()
03.333.112S

  • Cannulated surgical drill bit, single-use

400 KTP Laser Fiber - 00810077630693

400 KTP Laser Fiber
OPTICAL INTEGRITY INC
IN-0400S-FT-000-AUR-1
In Commercial Distribution

  • 00810077635582 ()
  • 00810077630693 ()

  • Outer Diameter: 400 Micrometer
11831

  • General/multiple surgical laser system beam guide, reusable

OSSDSIGN Cranioplug - 07350086550252

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
11 mm, 6 fixation-points
Not in Commercial Distribution

  • 17350086550259 ()
  • 07350086550252 ()
  • 27350086550256 ()

  • 6 fixation-points
  • Outer Diameter: 11 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

OSSDSIGN Cranioplug - 07350086550245

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
11 mm, 2 fixation-points
Not in Commercial Distribution

  • 17350086550242 ()
  • 07350086550245 ()
  • 27350086550249 ()

  • 2 fixation-points
  • Outer Diameter: 11 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized

OSSDSIGN Cranioplug - 07350086550238

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 - 07350086550221

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

CODMAN - 20886704042171

CODMAN Silicone Burr Hole Covers 3/8 Inch (9.5mm) dia.
Cerenovus, Inc.
82-6025
Not in Commercial Distribution

  • 20886704042171 ()
  • 10886704042174 ()
826025

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

CODMAN - 20886704042164

CODMAN Burr Hole Buttons
Cerenovus, Inc.
82-6010
Not in Commercial Distribution

  • 20886704042164 ()
  • 10886704042167 ()
826010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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