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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 - 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

DRIVEMEDICAL - 50822383145124

Canes & CrutchesAccessories Product Description: Utility Replace.Tips 7/8",Grey, RTL
Drive Devilbiss Healthcare
10390G-8
Not in Commercial Distribution

  • 50822383145124 ()


  • Walking aid tip

DRIVEMEDICAL - 50822383145070

Canes & CrutchesAccessories Product Description: Utility ReplceTips,1 1/8",Gry,8pr/cs,RTL
Drive Devilbiss Healthcare
10386G-8
Not in Commercial Distribution

  • 50822383145070 ()


  • Walking aid tip

Reison - 07332339229825

Tibia Support Short
Stille AB
Tibia Support Short
In Commercial Distribution

  • 07332339229825 ()
514-100367-K

  • External orthopaedic fixation system, reusable

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

iSy® Lab screwdriver - E219P531060601

iSy® Lab screwdriver
ALTATEC GmbH
P5310.6060
In Commercial Distribution

  • E219P531060601 ()
P5310.6060

  • Surgical screwdriver, reusable

TSP HIP FX PLATING SYSTEMSCREW EXTRACTOR, 4.5MM SCREW - 00887868129780

No Description
Biomet Orthopedics, LLC
14-451567
In Commercial Distribution

  • 00887868129780 ()

  • 4.5MM
14-451567

  • Surgical screwdriver, single-use

Stratum Ankle - 00810082893281

Stratum Ankle Outrigger 3.5MM Hex Driver sterile
Medartis Inc.
SAOUT35DRVS
In Commercial Distribution

  • 00810082893281 ()


  • Surgical screwdriver, single-use

Stratum Ankle - 00810082893229

Stratum Ankle Outrigger Cannulated Drill sterile
Medartis Inc.
SAOUTCANS
In Commercial Distribution

  • 00810082893229 ()


  • Cannulated surgical drill bit, single-use

Stratum Ankle - 00810082893090

Stratum Ankle T20 AO Driver sterile
Medartis Inc.
SAT20AOS
In Commercial Distribution

  • 00810082893090 ()


  • Surgical screwdriver, single-use
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