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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STABILIZING COLLET 18MM
ONKOS SURGICAL, INC.
K0051118E
In Commercial Distribution

  • B278K0051118E0 ()
K0051118E

  • General internal orthopaedic fixation system implantation kit
STABILIZING COLLET 16MM
ONKOS SURGICAL, INC.
K0051116E
In Commercial Distribution

  • B278K0051116E0 ()
K0051116E

  • General internal orthopaedic fixation system implantation kit
MicroFrance® Stratte tungsten needle holder, curved jaws, 200 mm length
INTEGRA MICROFRANCE
7945T
In Commercial Distribution

  • 10381780090830 ()
7945T

  • Suturing needle holder, reusable
MicroFrance® Cotton applicator, 1.2 mm diameter, 140 mm length
INTEGRA MICROFRANCE
7719-2
In Commercial Distribution

  • 10381780088486 ()
7719-2

  • Nasal snare, reusable
MicroFrance® Crile-Wood tungsten needle-holder, 200 mm
INTEGRA MICROFRANCE
720T
In Commercial Distribution

  • 10381780088448 ()
720T

  • Suturing needle holder, reusable
MicroFrance® Crile-Wood tungsten needle-holder, large jaws, 150 mm
INTEGRA MICROFRANCE
714T
In Commercial Distribution

  • 10381780088431 ()
714T

  • Suturing needle holder, reusable
MicroFrance® Halsey tungsten needle-holder, smooth jaws, 130 mm
INTEGRA MICROFRANCE
704T
In Commercial Distribution

  • 10381780088356 ()
704T

  • Suturing needle holder, reusable
MicroFrance® Halsey tungsten needle holder, 130 mm
INTEGRA MICROFRANCE
703T
In Commercial Distribution

  • 10381780088318 ()
703T

  • Suturing needle holder, reusable
MicroFrance® Crile-Wood tungsten needle-holder, 150 mm
INTEGRA MICROFRANCE
702T
In Commercial Distribution

  • 10381780088301 ()
702T

  • Suturing needle holder, reusable
NEEDLE HOLDER 701T 180MM MAYO HEGAR
INTEGRA MICROFRANCE
701T
In Commercial Distribution

  • 10381780088295 ()
701T

  • Suturing needle holder, reusable
Integra® Castroviejo Needle Holder, with Lock, Curved, Delicate, 10 mm Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3752011
In Commercial Distribution

  • 10381780088004 ()
3752011

  • Suturing needle holder, reusable
Integra® Castroviejo Needle Holder, Straight, Delicate, with Lock, 10 mm Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3752008
In Commercial Distribution

  • 10381780087991 ()
3752008

  • Suturing needle holder, reusable
Integra® Webster Needle Holder ,Smooth Jaws, 4-7/8"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744040
In Commercial Distribution

  • 10381780087748 ()
3744040

  • Suturing needle holder, reusable
Integra® Mayo-Hegar Needle Holder, Tungsten Carbide, 8"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744032
In Commercial Distribution

  • 10381780087731 ()
3744032

  • Suturing needle holder, reusable
Integra® Mayo-Hegar Needle Holder, Tungsten Carbide, 7"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744031
In Commercial Distribution

  • 10381780087724 ()
3744031

  • Suturing needle holder, reusable
Integra® Mayo-Hegar Needle Holder, Tungsten Carbide, 6-1/4"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744030
In Commercial Distribution

  • 10381780087717 ()
3744030

  • Suturing needle holder, reusable
Integra® Ryder Needle Holder, Tungsten Carbide, 1mm Jaws, 5"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744027
In Commercial Distribution

  • 10381780087700 ()
3744027

  • Suturing needle holder, reusable
Integra® Crile-Wood Needle Holder , Straight, Tungsten Carbide, 7"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744026
In Commercial Distribution

  • 10381780087694 ()
3744026

  • Suturing needle holder, reusable
Integra® Crile-Wood Needle Holder , Straight, Tungsten Carbide, 5-7/8"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744025
In Commercial Distribution

  • 10381780087687 ()
3744025

  • Suturing needle holder, reusable
Integra® Olsen-Webster Needle Holder, Tungsten Carbide, Serrated Jaws, 4-3/4"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744020
In Commercial Distribution

  • 10381780087670 ()
3744020

  • Suturing needle holder, reusable
Integra® Olsen-Webster Needle Holder, Tungsten Carbide, Smooth Jaws, 4-3/4"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744019
In Commercial Distribution

  • 10381780087663 ()
3744019

  • Suturing needle holder, reusable
Integra® Halsey Needle Holder, Tungsten Carbide, Smooth Jaws, 5-1/4"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744016
In Commercial Distribution

  • 10381780087656 ()
3744016

  • Suturing needle holder, reusable
Integra® Halsey Needle Holder, Tungsten Carbide, Serrated Jaws, 5-1/4"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744015
In Commercial Distribution

  • 10381780087649 ()
3744015

  • Suturing needle holder, reusable
Integra® Webster Needle Holder, Tungsten Carbide, Smooth Jaws, 5-1/8"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744012
In Commercial Distribution

  • 10381780087632 ()
3744012

  • Suturing needle holder, reusable
Integra® Crile-Wood Needle Holder
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744010
In Commercial Distribution

  • 10381780087625 ()
3744010

  • Suturing needle holder, reusable
Integra® Derf Needle Holder, Standard Pattern
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744003
In Commercial Distribution

  • 10381780087618 ()
3744003

  • Suturing needle holder, reusable
Integra® Webster Needle Holder, Smooth Jaws
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744001
In Commercial Distribution

  • 10381780087601 ()
3744001

  • Suturing needle holder, reusable
Integra® Brown Needle Holder, Convex, Fine Serrated
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3744000
In Commercial Distribution

  • 10381780087595 ()
3744000

  • Suturing needle holder, reusable
Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-110
In Commercial Distribution

  • 00814008029822 ()


  • General internal orthopaedic fixation system implantation kit
Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-109
In Commercial Distribution

  • 00814008029815 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: CC Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CCI
In Commercial Distribution

  • 00814008029785 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Awl Small. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-112
In Commercial Distribution

  • 00814008029778 ()


  • General internal orthopaedic fixation system implantation kit
Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-108
In Commercial Distribution

  • 00814008029754 ()


  • General internal orthopaedic fixation system implantation kit
Rod Template. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-107
In Commercial Distribution

  • 00814008029747 ()


  • General internal orthopaedic fixation system implantation kit
Linear Persuader Counter Torque. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-105
In Commercial Distribution

  • 00814008026289 ()


  • General internal orthopaedic fixation system implantation kit
Drill, for 7.5MM. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-043
In Commercial Distribution

  • 00814008026265 ()


  • General internal orthopaedic fixation system implantation kit
Drill, for 6.5MM. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-042
In Commercial Distribution

  • 00814008026258 ()


  • General internal orthopaedic fixation system implantation kit
Open Head Turner. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-074
In Commercial Distribution

  • 00814008026227 ()


  • General internal orthopaedic fixation system implantation kit
Open Rod De-Rotator. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-073
In Commercial Distribution

  • 00814008026210 ()


  • General internal orthopaedic fixation system implantation kit
Open Rod Holder. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000T-068
In Commercial Distribution

  • 00814008026166 ()


  • General internal orthopaedic fixation system implantation kit
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