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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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Focus - 00810005662161

Pedicle Screw Case, Instruments. 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-1000C-102
In Commercial Distribution

  • 00810005662161 ()


  • Surgical instrument/implant rack

Focus - 00810005662154

Pedicle Screw Case 2 INSERT 3. 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-1000C-204
In Commercial Distribution

  • 00810005662154 ()


  • Surgical instrument/implant rack

Focus - 00810005662147

Pedicle Screw Case 2 Base, Implants. 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-1000C-211
In Commercial Distribution

  • 00810005662147 ()


  • Surgical instrument/implant rack

Focus - 00810005662130

Pedicle Screw Case 1 INSERT 2. 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-1000C-202
In Commercial Distribution

  • 00810005662130 ()


  • Surgical instrument/implant rack

Focus - 00810005662123

Pedicle Screw Case 1 INSERT 1. 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-1000C-203
In Commercial Distribution

  • 00810005662123 ()


  • Surgical instrument/implant rack

Focus - 00810005662116

Pedicle Screw Case 1 Lid. 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-1000C-101
In Commercial Distribution

  • 00810005662116 ()


  • Surgical instrument/implant rack

Focus - 00810005662109

Pedicle Screw Case 1 Base, Implants. 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-1000C-201
In Commercial Distribution

  • 00810005662109 ()


  • Surgical instrument/implant rack

Fresh Cells - 30014613339571

Hela, MWP, 96W24F
DIAGNOSTIC HYBRIDS, INC.
72-9624C
In Commercial Distribution

  • 30014613339571 ()
72-9624C

  • Cell culture line IVD

Fresh Cells - 30014613339564

VERO SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
84-0101
In Commercial Distribution

  • 30014613339564 ()
84-0101

  • Cell culture line IVD

Fresh Cells - 30014613339281

Vero E6, MWP, 96W96F 90% conf
DIAGNOSTIC HYBRIDS, INC.
50-91-9696-90
In Commercial Distribution

  • 30014613339281 ()
50-91-9696-90

  • Cell culture line IVD

Fresh Cells - 30014613339274

Vero E6, MWP, 96W96F
DIAGNOSTIC HYBRIDS, INC.
91-9696
In Commercial Distribution

  • 30014613339274 ()
91-9696

  • Cell culture line IVD

Fresh Cells - 30014613338420

Super-BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
70-T225
In Commercial Distribution

  • 30014613338420 ()
70-T225

  • Cell culture line IVD

Fresh Cells - 30014613338413

BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T225
In Commercial Distribution

  • 30014613338413 ()
53-T225

  • Cell culture line IVD

Fresh Cells - 30014613338307

RHMK FLK 225
DIAGNOSTIC HYBRIDS, INC.
49-T225DH
In Commercial Distribution

  • 30014613338307 ()
49-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613338260

MDCK FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
83-T225DH
In Commercial Distribution

  • 30014613338260 ()
83-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613335627

CITES RHMK FLK
DIAGNOSTIC HYBRIDS, INC.
C49-T150A
In Commercial Distribution

  • 30014613335627 ()
C49-T150A

  • Cell culture line IVD

Fresh Cells - 30014613335610

CITES KIDNEY RHESUS TUBE W/A
DIAGNOSTIC HYBRIDS, INC.
C49-0600A
In Commercial Distribution

  • 30014613335610 ()
C49-0600A

  • Cell culture line IVD

Fresh Cells - 30014613335603

CITES KIDNEY RHESUS SV W/C AN
DIAGNOSTIC HYBRIDS, INC.
C49-0102A
In Commercial Distribution

  • 30014613335603 ()
C49-0102A

  • Cell culture line IVD

Fresh Cells - 30014613335597

RHMK P1 FROZEN SUSP. CITES
DIAGNOSTIC HYBRIDS, INC.
C49-00010P
In Commercial Distribution

  • 30014613335597 ()
C49-00010P

  • Cell culture line IVD

Fresh Cells - 30014613335511

MADIN-DARBY CANINE KIDNEY T150
DIAGNOSTIC HYBRIDS, INC.
99-84121903-T150
In Commercial Distribution

  • 30014613335511 ()
99-84121903-T150

  • Cell culture line IVD
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