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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INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR X-LARGE
DEPUY (IRELAND)
6105-30-060
In Commercial Distribution

  • 10603295538950 ()
610530060

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR LARGE
DEPUY (IRELAND)
6105-30-050
In Commercial Distribution

  • 10603295538943 ()
610530050

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR MEDIUM
DEPUY (IRELAND)
6105-30-040
In Commercial Distribution

  • 10603295538936 ()
610530040

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR X- SMALL
DEPUY (IRELAND)
6105-30-020
In Commercial Distribution

  • 10603295538912 ()
610530020

  • Bone-resection orthopaedic reamer, reusable
SCREW DRIVER, HEX HEAD
Encore Medical, L.P.
801-01-042
In Commercial Distribution

  • 00888912127165 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER,HEX REVISION
DJO, LLC
800-01-263
In Commercial Distribution

  • 00888912123495 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Staple Tamp, Large
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000002
In Commercial Distribution

  • B471240000020 ()


  • Orthopaedic bone staple driver
Staple Tamp, Small
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000001
In Commercial Distribution

  • B471240000010 ()


  • Orthopaedic bone staple driver
Drill Bit 5.0mmx230mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250230
In Commercial Distribution

  • B471212502300 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 230 Millimeter


  • Cannulated surgical drill bit, single-use
Drill Bit 5.0mmx160mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250160
In Commercial Distribution

  • B471212501600 ()

  • Length: 160 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Cannulated surgical drill bit, single-use
Cannulated Drill, AO, 1.9mm x 135mm
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21119135
In Commercial Distribution

  • B471211191350 ()


  • Cannulated surgical drill bit, single-use
Drill Bit 2.8mmx150mm AO Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21028150
In Commercial Distribution

  • B471210281500 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 150 Millimeter


  • Cannulated surgical drill bit, single-use
Drill Bit 2.8mmx100mm AO Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21028100
In Commercial Distribution

  • B471210281000 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 100 Millimeter


  • Cannulated surgical drill bit, single-use
Drill Bit 2.0mmx100mm AO Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21020100
In Commercial Distribution

  • B471210201000 ()

  • Length: 100 Millimeter
  • Outer Diameter: 2.0 Millimeter


  • Cannulated surgical drill bit, single-use
Drill Bit 1.6mmx100mm AO Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21016100
In Commercial Distribution

  • B471210161000 ()

  • Outer Diameter: 1.6 Millimeter
  • Length: 100 Millimeter


  • Cannulated surgical drill bit, single-use
Driver Handle Hudson Ratchet Straight Reusable
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20191000
In Commercial Distribution

  • B471201910000 ()


  • Surgical instrument handle, non-torque-limiting
Driver Handle Hudson Fixed Straight Single Use
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20180000
In Commercial Distribution

  • B471201800000 ()


  • Surgical torque wrench, single-use
Driver Tip Hexalobe T-30 Hudson SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20109930
In Commercial Distribution

  • B471201099300 ()


  • Surgical screwdriver, single-use
Driver Tip Hexalobe T-20 Hudson SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20109920
In Commercial Distribution

  • B471201099200 ()


  • Surgical screwdriver, single-use
Driver Handle AO Fixed Spinner Straight Reusable
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20092000
In Commercial Distribution

  • B471200920000 ()


  • Surgical instrument handle, non-torque-limiting
Driver Handle AO Fixed Straight Single Use
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20080000
In Commercial Distribution

  • B471200800000 ()


  • Surgical torque wrench, single-use
Driver Tip Hexalobe T-15 Solid 100mm
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20019915
In Commercial Distribution

  • B471200199150 ()


  • Surgical screwdriver, single-use
Driver Tip Hexalobe T-20 AO SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20009920
In Commercial Distribution

  • B471200099200 ()


  • Surgical screwdriver, single-use
Driver Tip Hexalobe T-10 AO SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20009910
In Commercial Distribution

  • B471200099100 ()


  • Surgical screwdriver, single-use
Driver Tip Hexalobe T-8 AO SS
GRAMERCY EXTREMITY ORTHOPEDICS LLC
20009908
In Commercial Distribution

  • B471200099080 ()


  • Surgical screwdriver, single-use
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
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
Reusable accessory Cutting insert
3D SYSTEMS, INC.
Metal Slot (45mm)
In Commercial Distribution

  • 00816847021364 ()

  • Length: 45 Millimeter


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

  • 00816847021357 ()

  • Length: 40 Millimeter


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

  • 00816847021340 ()

  • Length: 35 Millimeter


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

  • 00816847021333 ()

  • Length: 25 Millimeter


  • Osteotomy guide, reusable
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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