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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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30-36 mm POLYAXIAL CROSS CONNECTOR
Stryker Corporation
48133230
In Commercial Distribution

  • 04546540515087 ()
48133230

  • Bone-screw internal spinal fixation system connector
24-30 mm POLYAXIAL CROSS CONNECTOR
Stryker Corporation
48133224
In Commercial Distribution

  • 04546540515070 ()
48133224

  • Bone-screw internal spinal fixation system connector
No Description
OSADA ELECTRIC CO.,LTD.
SC point 5
In Commercial Distribution

  • 04582227360229 ()
16405

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
No Description
W.H. Holden, Inc.
10-6145
In Commercial Distribution

  • D9281061450 ()


  • Dental suction system cannula, reusable
The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. The device is accessory to the Cube 4D Navigation system.
Fiagon GmbH
E012901
In Commercial Distribution

E012901

  • Multi-purpose stereotactic surgery system
No Description
CHARMANT INC.
24-0001
In Commercial Distribution

  • 00883475951660 ()


  • Gastrointestinal endoscopic clip applier
No Description
Biomet Orthopedics, LLC
31-109235
In Commercial Distribution

  • 00880304303836 ()
31-109235

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
31-109233
In Commercial Distribution

  • 00880304303829 ()
31-109233

  • Orthopaedic inorganic implant inserter/extractor, reusable
The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ,PointerShell. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0129011 ()
  • EFIAE0129010 ()


  • Multi-purpose stereotactic surgery system
No Description
AMI Agency for Medical Innovations GmbH
ESI1530
Not in Commercial Distribution

  • EAMIESI15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
ESI1530

  • Electrosurgical handpiece, reusable
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