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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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Arthrex® - 00888867500471

Driver Shaft, T15, Retaining, AO
ARTHREX, INC.
AR-7650-09
In Commercial Distribution

  • 00888867500471 ()
AR-7650-09

  • Orthopaedic implant driver

Arthrex® - 00888867498518

Reamer, Cannulated, 5.0mm, Sterile
ARTHREX, INC.
AR-8974-50S
In Commercial Distribution

  • 00888867498518 ()
AR-8974-50S

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498501

Reamer, Cannulated, 5.0mm
ARTHREX, INC.
AR-8974-50
In Commercial Distribution

  • 00888867498501 ()
AR-8974-50

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498495

Reamer, Ø2.8mm, AO Connect, Sterile
ARTHREX, INC.
AR-8974-28S
In Commercial Distribution

  • 00888867498495 ()
AR-8974-28S

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498488

Reamer, Ø2.8mm, AO Connect
ARTHREX, INC.
AR-8974-28
In Commercial Distribution

  • 00888867498488 ()
AR-8974-28

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498471

Reamer, Ø2.5mm, AO Connect, Sterile
ARTHREX, INC.
AR-8974-26S
In Commercial Distribution

  • 00888867498471 ()
AR-8974-26S

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867498464

Reamer, Ø2.5mm, AO Connect
ARTHREX, INC.
AR-8974-26
In Commercial Distribution

  • 00888867498464 ()
AR-8974-26

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867447981

Lag Screw Inserter, Trochanteric Nail
ARTHREX, INC.
AR-9095-64
In Commercial Distribution

  • 00888867447981 ()
AR-9095-64

  • Surgical screwdriver, reusable

Arthrex® - 00888867447936

Lag Screw Inserter
ARTHREX, INC.
AR-9095-58
In Commercial Distribution

  • 00888867447936 ()
AR-9095-58

  • Surgical screwdriver, reusable

Arthrex® - 00888867447912

Compression Sleeve, Lag Screw Inserter
ARTHREX, INC.
AR-9095-56
In Commercial Distribution

  • 00888867447912 ()
AR-9095-56

  • Surgical screwdriver, reusable

Arthrex® - 00888867447783

Ball Spike
ARTHREX, INC.
AR-9095-30
In Commercial Distribution

  • 00888867447783 ()
AR-9095-30

  • Surgical screwdriver, reusable

Arthrex® - 00888867447738

Screw Driver Handle, Cann, Lg Hudson
ARTHREX, INC.
AR-9095-25
In Commercial Distribution

  • 00888867447738 ()
AR-9095-25

  • Surgical instrument handle, non-torque-limiting

Arthrex® - 00888867447585

End Cap Hex Driver, Large Hudson, 9/32"
ARTHREX, INC.
AR-9095-08
In Commercial Distribution

  • 00888867447585 ()
AR-9095-08

  • Surgical screwdriver, reusable

Arthrex® - 00888867447578

Ball Hex Driver, Large Hudson, 9/32"
ARTHREX, INC.
AR-9095-07
In Commercial Distribution

  • 00888867447578 ()
AR-9095-07

  • Surgical screwdriver, reusable

Arthrex® - 00888867447561

5.0mm Hex Screwdriver, NS AR Screw
ARTHREX, INC.
AR-9095-06
In Commercial Distribution

  • 00888867447561 ()
AR-9095-06

  • Surgical screwdriver, reusable

Arthrex® - 00888867447554

3.5mm Hex Screwdriver, NS AR Screw
ARTHREX, INC.
AR-9095-05
In Commercial Distribution

  • 00888867447554 ()
AR-9095-05

  • Surgical screwdriver, reusable

Arthrex® - 00888867447523

Lag Screw Drill, 10.3 mm
ARTHREX, INC.
AR-9095-02
In Commercial Distribution

  • 00888867447523 ()
AR-9095-02

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867445086

Power Hex Screw Driver, Short, 5.0mm
ARTHREX, INC.
AR-9097-14
In Commercial Distribution

  • 00888867445086 ()
AR-9097-14

  • Surgical screwdriver, reusable

Arthrex® - 00888867445062

Power Hex Screw Driver, 5.0mm
ARTHREX, INC.
AR-9097-12
In Commercial Distribution

  • 00888867445062 ()
AR-9097-12

  • Surgical screwdriver, reusable

Arthrex® - 00888867439412

Drill, Cannulated, LG Hudson, 5.5mm,Strl
ARTHREX, INC.
AR-9097-01S
In Commercial Distribution

  • 00888867439412 ()
AR-9097-01S

  • Cannulated surgical drill bit, single-use

Arthrex® - 00888867435988

Driver Shaft, T10, Retaining, AO, Power
ARTHREX, INC.
AR-7650-13
In Commercial Distribution

  • 00888867435988 ()
AR-7650-13

  • Orthopaedic implant driver

Arthrex® - 00888867426979

Mallet
ARTHREX, INC.
AR-S4100-100-000
In Commercial Distribution

  • 00888867426979 ()
AR-S4100-100-000

  • Surgical mallet

MSI - B4191746230

No Description
Modern Surgical Instruments LLC
17-4623
In Commercial Distribution

  • B4191746230 ()


  • Surgical screwdriver, reusable

VSP System - 00816847020794

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Fibula Cutting Guide
In Commercial Distribution

  • 00816847020794 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020787

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Fibula Marking Guide with Implant Placement
In Commercial Distribution

  • 00816847020787 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020770

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.
3D SYSTEMS, INC.
Fibula Cutting Guide with Implant Placement
In Commercial Distribution

  • 00816847020770 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020763

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Surgical Positioning Guide
In Commercial Distribution

  • 00816847020763 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020756

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Surgical Positioning Template
In Commercial Distribution

  • 00816847020756 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020749

A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of time. Once the bone repositioning guide stabilizes the position of the patient’s bone; the surgeon can determine a permanent solution
3D SYSTEMS, INC.
Bone Repositioning Guide
In Commercial Distribution

  • 00816847020749 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020732

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Maxillofacial Positioning Guide
In Commercial Distribution

  • 00816847020732 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020725

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Bone Positioning Wedge
In Commercial Distribution

  • 00816847020725 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020718

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Distractor Drilling Guide
In Commercial Distribution

  • 00816847020718 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020701

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Distractor Marking Guide
In Commercial Distribution

  • 00816847020701 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020695

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Trauma Positioning Guide
In Commercial Distribution

  • 00816847020695 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System, VSP Cranial - 00816847020688

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Trauma Drilling Guide
In Commercial Distribution

  • 00816847020688 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020671

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Genioplasty Marking Guide
In Commercial Distribution

  • 00816847020671 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020664

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Genioplasty Positioning Guide
In Commercial Distribution

  • 00816847020664 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020657

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Genioplasty Drilling Guide
In Commercial Distribution

  • 00816847020657 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020640

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Sagittal Split Marking Guide with Predictive Hole Placement
In Commercial Distribution

  • 00816847020640 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020633

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Sagittal Split Marking Guide
In Commercial Distribution

  • 00816847020633 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020626

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
Proximal Segment Positioning Guide
In Commercial Distribution

  • 00816847020626 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020619

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
Proximal Segment Drilling Guide
In Commercial Distribution

  • 00816847020619 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020602

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
LeFort Marking Guide with Predictive Hole Placement
In Commercial Distribution

  • 00816847020602 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020596

A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes
3D SYSTEMS, INC.
LeFort Marking Guide
In Commercial Distribution

  • 00816847020596 ()


  • Custom-made orthopaedic/craniofacial surgical guide

VSP System - 00816847020589

A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to allow manipulation of free floating bony anatomy.
3D SYSTEMS, INC.
LeFort Positioning Guide
In Commercial Distribution

  • 00816847020589 ()


  • Custom-made orthopaedic/craniofacial surgical guide

Spine Instruments - 07630345752758

Reduction driver 2.0
Medacta International SA
03.52.10.0732
In Commercial Distribution

  • 07630345752758 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spine Instruments - 07630345752499

Long rounded handle - reduction driver
Medacta International SA
03.51.10.0492
In Commercial Distribution

  • 07630345752499 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Innomed, Inc. - 00840277106520

Slaphammer for Orthovise Small
INNOMED, INC.
3955
In Commercial Distribution

  • 00840277106520 ()
3955

  • Surgical mallet

Innomed, Inc. - 00840277106513

Slaphammer for Extractor Extra Large
INNOMED, INC.
3935
In Commercial Distribution

  • 00840277106513 ()
3935

  • Surgical mallet

Innomed, Inc. - 00840277105134

Modified Pin Inserter/Extractor Slaphammer
INNOMED, INC.
3040-M
In Commercial Distribution

  • 00840277105134 ()
3040-M

  • Surgical mallet
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