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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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Adapter Socket Driver
Orthalign, Inc.
403347
In Commercial Distribution

  • 00851977007857 ()
403347

  • Orthopaedic surgical procedure kit, non-medicated, reusable
6mm Hex Driver
Orthalign, Inc.
403351
In Commercial Distribution

  • 00851977007659 ()
403351

  • Orthopaedic surgical procedure kit, non-medicated, reusable
6MM Hex Driver - Purchased
Orthalign, Inc.
403350
In Commercial Distribution

  • 00851977007642 ()
403350

  • Orthopaedic surgical procedure kit, non-medicated, reusable
No Description
General Vibronics, LLC
GVM2
In Commercial Distribution

  • 00860013508616 ()


  • Medium-wave diathermy treatment system generator
#1 MEAD IMMUNITY MALLET - GERMAN STYLE
HU-FRIEDY MFG. CO., LLC
MAL1E
In Commercial Distribution

  • 10889950079673 ()
MAL1E

  • Surgical mallet
Occipital Screw, 12mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5012
In Commercial Distribution

  • 10889981042967 ()

  • 12mm
50-5012

  • Cannulated surgical drill bit, single-use
Occipital Screw, 10mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5010
In Commercial Distribution

  • 10889981042943 ()

  • 10mm
50-5010

  • Cannulated surgical drill bit, single-use
Occipital Screw, 8mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5008
In Commercial Distribution

  • 10889981042929 ()

  • 8mm
50-5008

  • Cannulated surgical drill bit, single-use
Occipital Screw, 6mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5006
In Commercial Distribution

  • 10889981042905 ()

  • 6mm
50-5006

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia x 50mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-4550
Not in Commercial Distribution

  • 10889981042899 ()

  • 4.5 Dia X 50mm
50-4550

  • Cannulated surgical drill bit, single-use
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