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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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Specials - 10889981321581

Tulip Stab and Grab Driver
Seaspine Orthopedics Corporation
SR-1172
In Commercial Distribution

  • 10889981321581 ()
SR-1172

  • Orthopaedic implant driver

Specials - 10889981321499

Depth Stop, Extended Driver Sleeve, 20mm
Seaspine Orthopedics Corporation
SR-1171-20
In Commercial Distribution

  • 10889981321499 ()
SR-1171-20

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981321482

Depth Stop, Extended Driver Sleeve, 5mm
Seaspine Orthopedics Corporation
SR-1171-05
In Commercial Distribution

  • 10889981321482 ()
SR-1171-05

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981321239

Shoreline Flex Driver
Seaspine Orthopedics Corporation
SR-1010
In Commercial Distribution

  • 10889981321239 ()
SR-1010

  • Orthopaedic implant driver

Specials - 10889981326012

Sleeve, MIS Locking Navigation Driver
Seaspine Orthopedics Corporation
SR-1183-20
In Commercial Distribution

  • 10889981326012 ()
SR-1183-20

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981326005

MIS Locking Navigation Driver
Seaspine Orthopedics Corporation
SR-1183
In Commercial Distribution

  • 10889981326005 ()
SR-1183

  • Orthopaedic implant driver

Specials - 10889981325350

Shortened Reduction Driver, Tri-Flat
Seaspine Orthopedics Corporation
SR-1230
In Commercial Distribution

  • 10889981325350 ()
SR-1230

  • Orthopaedic implant driver

Specials - 10889981325077

Screw Shank Driver, Reduced Thread
Seaspine Orthopedics Corporation
SR-1203
In Commercial Distribution

  • 10889981325077 ()
SR-1203

  • Orthopaedic implant driver

Specials - 10889981325060

Poly Screwdriver w/ Modified Tip
Seaspine Orthopedics Corporation
SR-1207
In Commercial Distribution

  • 10889981325060 ()
SR-1207

  • Orthopaedic implant driver

VECTOR TAS - 10889989000051

VECTOR TAS DRIVER TIP 22MM - Qty 2
ORMCO CORPORATION
601-0012
In Commercial Distribution

  • 10889989000051 ()
  • 00889989000054 ()

  • 22mm Driver Tip Diameter


  • Orthodontic anchoring screw

VECTOR TAS - 10889989000044

VECTOR TAS DRIVER TIP 40MM - Qty 2
ORMCO CORPORATION
601-0011
In Commercial Distribution

  • 10889989000044 ()
  • 00889989000047 ()

  • 40mm Driver Tip Diameter


  • Orthodontic anchoring screw

Mariner MCT - 10889987170114

Cortical Screw Shank Driver, Long
Seaspine Orthopedics Corporation
MC2-003012
Not in Commercial Distribution

  • 10889987170114 ()
MC2-003012

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MCT - 10889987170107

Cortical Screw Shank Driver, Short
Seaspine Orthopedics Corporation
MC2-003011
Not in Commercial Distribution

  • 10889987170107 ()
MC2-003011

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MCT - 10889987170091

Cortical Screw Shank Driver
Seaspine Orthopedics Corporation
MC2-003010
Not in Commercial Distribution

  • 10889987170091 ()
MC2-003010

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NA - 06009544032540

Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22U-S
In Commercial Distribution

  • 06009544032540 ()


  • Surgical screwdriver, reusable

NA - 06009544032533

Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22U-M
In Commercial Distribution

  • 06009544032533 ()


  • Surgical screwdriver, reusable

NA - 06009544032526

Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22U-L
In Commercial Distribution

  • 06009544032526 ()


  • Surgical screwdriver, reusable

NA - 06009544032519

Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-HHD-22U-S
In Commercial Distribution

  • 06009544032519 ()


  • Surgical screwdriver, reusable

NA - 06009544032502

Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-HHD-22U-M
In Commercial Distribution

  • 06009544032502 ()


  • Surgical screwdriver, reusable

NA - 06009544032496

Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-HHD-22U-L
In Commercial Distribution

  • 06009544032496 ()


  • Surgical screwdriver, reusable

NA - 06009544032489

Instrument, 1.22mm/1.27mm Universal Hex Driver, Short
SOUTHERN IMPLANTS (PTY) LTD
I-HD-22U-S
In Commercial Distribution

  • 06009544032489 ()


  • Surgical screwdriver, reusable

NA - 06009544032472

Instrument, 1.22mm/1.27mm Universal Hex Driver, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-HD-22U-M
In Commercial Distribution

  • 06009544032472 ()


  • Surgical screwdriver, reusable

NA - 06009544026969

Instrument, 1.27mm Hex Driver, Long Handle
SOUTHERN IMPLANTS (PTY) LTD
I-HD-27-LH
In Commercial Distribution

  • 06009544026969 ()


  • Surgical screwdriver, reusable

Sierra™ - 10889981042967

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

Sierra™ - 10889981042950

Occipital Screw, 11mm. 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
50-5011
In Commercial Distribution

  • 10889981042950 ()

  • 11mm
50-5011

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042943

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

Sierra™ - 10889981042936

Occipital Screw, 9mm. 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
50-5009
In Commercial Distribution

  • 10889981042936 ()

  • 9mm
50-5009

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042929

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

Sierra™ - 10889981042912

Occipital Screw, 7mm. 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
50-5007
In Commercial Distribution

  • 10889981042912 ()

  • 7mm
50-5007

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042905

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™ - 10889981042899

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

Sierra™ - 10889981042882

Sierra Screw,4.5 Dia x 45mm. 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
50-4545
Not in Commercial Distribution

  • 10889981042882 ()

  • 4.5 Dia X 45mm
50-4545

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042875

Sierra Screw,4.5 Dia x 40mm. 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
50-4540
Not in Commercial Distribution

  • 10889981042875 ()

  • 4.5 Dia X 40mm
50-4540

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042868

Sierra Screw,4.5 Dia x 38mm. 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
50-4538
Not in Commercial Distribution

  • 10889981042868 ()

  • 4.5 Dia X 38mm
50-4538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042851

Sierra Screw,4.5 Dia x 36mm. 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
50-4536
Not in Commercial Distribution

  • 10889981042851 ()

  • 4.5 Dia X 36mm
50-4536

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042844

Sierra Screw,4.5 Dia x 34mm. 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
50-4534
Not in Commercial Distribution

  • 10889981042844 ()

  • 4.5 Dia X 34mm
50-4534

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042837

Sierra Screw,4.5 Dia x 32mm. 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
50-4532
In Commercial Distribution

  • 10889981042837 ()

  • 4.5 Dia X 32mm
50-4532

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042820

Sierra Screw,4.5 Dia x 30mm. 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
50-4530
Not in Commercial Distribution

  • 10889981042820 ()

  • 4.5 Dia X 30mm
50-4530

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042813

Sierra Screw,4.5 Dia x 28mm. 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
50-4528
In Commercial Distribution

  • 10889981042813 ()

  • 4.5 Dia X 28mm
50-4528

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042790

Sierra Screw,4.5 Dia x 24mm. 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
50-4524
In Commercial Distribution

  • 10889981042790 ()

  • 4.5 Dia X 24mm
50-4524

  • Cannulated surgical drill bit, single-use
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