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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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GEO Bone Screw System - B471200099100

Driver Tip Hexalobe T-10 AO SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20009910
In Commercial Distribution

  • B471200099100 ()


  • Surgical screwdriver, single-use

GEO Bone Screw System - B471200099080

Driver Tip Hexalobe T-8 AO SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20009908
In Commercial Distribution

  • B471200099080 ()


  • Surgical screwdriver, single-use

VSP System, VSP Cranial - 00816847021463

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Anatomical Model
In Commercial Distribution

  • 00816847021463 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021456

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Full Skull Model
In Commercial Distribution

  • 00816847021456 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021364

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (45mm)
In Commercial Distribution

  • 00816847021364 ()

  • Length: 45 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021357

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (40mm)
In Commercial Distribution

  • 00816847021357 ()

  • Length: 40 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021340

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (35mm)
In Commercial Distribution

  • 00816847021340 ()

  • Length: 35 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021333

Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (25mm)
In Commercial Distribution

  • 00816847021333 ()

  • Length: 25 Millimeter


  • Osteotomy guide, reusable

VSP System, VSP Cranial - 00816847021326

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (1.1 mm & 2.3 mm Screws)
In Commercial Distribution

  • 00816847021326 ()

  • Outer Diameter: 1.0 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021319

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (1mm Pre-Drill)
In Commercial Distribution

  • 00816847021319 ()

  • Outer Diameter: 1.0 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021302

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (2.3 mm & 2.7 mm Screws)
In Commercial Distribution

  • 00816847021302 ()

  • Outer Diameter: 2.3 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021296

Reusable accessory drill guide
3D SYSTEMS, INC.
Drill Guide (2.0 mm Screws)
In Commercial Distribution

  • 00816847021296 ()

  • Outer Diameter: 2.0 Millimeter


  • Surgical drill guide, reusable

VSP System, VSP Cranial - 00816847021289

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.
3D SYSTEMS, INC.
Implant Template
In Commercial Distribution

  • 00816847021289 ()


  • Surgical implant template, single-use

VSP System, VSP Cranial - 00816847021272

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.
3D SYSTEMS, INC.
Bone Graft Template
In Commercial Distribution

  • 00816847021272 ()


  • Surgical implant template, single-use

VSP System, VSP Cranial - 00816847021265

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.
3D SYSTEMS, INC.
Graft Pre-Contouring Template
In Commercial Distribution

  • 00816847021265 ()


  • Surgical implant template, single-use

VSP System - 00816847021258

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Mandible Model
In Commercial Distribution

  • 00816847021258 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021241

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Resected Maxilla Model
In Commercial Distribution

  • 00816847021241 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021234

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Maxilla/Mandible 2-Piece Model
In Commercial Distribution

  • 00816847021234 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021227

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Maxilla/Mandible 1-Piece Model
In Commercial Distribution

  • 00816847021227 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021210

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Full Skull Model
In Commercial Distribution

  • 00816847021210 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021203

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Mandible Model
In Commercial Distribution

  • 00816847021203 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021197

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Maxilla Model
In Commercial Distribution

  • 00816847021197 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021180

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Perfected Anatomical Model
In Commercial Distribution

  • 00816847021180 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021173

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Mirrored Anatomical Model
In Commercial Distribution

  • 00816847021173 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021166

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Repositioned Maxilla/Mandible 2-Piece Model
In Commercial Distribution

  • 00816847021166 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021159

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Repositioned Maxilla/Mandible 1-Piece Model
In Commercial Distribution

  • 00816847021159 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021142

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Repositioned Full Skull Model
In Commercial Distribution

  • 00816847021142 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021135

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Repositioned Mandible Model
In Commercial Distribution

  • 00816847021135 ()


  • Custom-made organ/bone anatomy model

VSP System - 00816847021128

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Repositioned Maxilla Model
In Commercial Distribution

  • 00816847021128 ()


  • Custom-made organ/bone anatomy model

VSP System, VSP Cranial - 00816847021111

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
3D SYSTEMS, INC.
Repositioned Anatomical Model
In Commercial Distribution

  • 00816847021111 ()


  • Custom-made organ/bone anatomy model
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