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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The Burr Hole Cover package contains 1 Burr Hole Cover.
Neuropace, Inc.
8110
In Commercial Distribution

  • 00855547005205 ()

  • Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
  • Outer Diameter: 14 Millimeter


  • Cranial bur hole cover
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005175 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005168 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005151 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-300M-K
In Commercial Distribution

  • 00855547005120 ()


  • Brain-responsive electrical stimulation system
Guidewire Driver
Si-Bone Inc.
501323
In Commercial Distribution

  • 00855369008705 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Torx Driver
Si-Bone Inc.
501243
In Commercial Distribution

  • 00855369008699 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Nav Adapter - Driver
Si-Bone Inc.
400291
In Commercial Distribution

  • 00855369008682 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Driver Sleeve 1
Si-Bone Inc.
400248
In Commercial Distribution

  • 00855369008521 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Driver Sleeve 2
Si-Bone Inc.
400262
In Commercial Distribution

  • 00855369008514 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Torx Driver, Cannulated
Si-Bone Inc.
501129
In Commercial Distribution

  • 00855369008484 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
No Description
SYNCARDIA SYSTEMS, LLC
297043-001
In Commercial Distribution

  • 00858000003237 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
297032-100
In Commercial Distribution

  • 00858000003206 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397001-001
In Commercial Distribution

  • 00858000003145 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
595000-001
In Commercial Distribution

  • 00858000003121 ()
  • 10858000003128 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397002-001
In Commercial Distribution

  • 00858000003107 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
Eca Medical Instruments
1005
In Commercial Distribution

  • 00857676008775 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-003
In Commercial Distribution

  • 00857676008768 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-002
In Commercial Distribution

  • 00857676008751 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-001
In Commercial Distribution

  • 00857676008744 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
Fixed Driver AO, Small Axial
In Commercial Distribution

  • 00857676008218 ()
806-004

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
Eca Medical Instruments
Fixed Driver AO, Small Axial
In Commercial Distribution

  • 00857676008201 ()
806-003

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
Eca Medical Instruments
2.4 mm Volar Distal Radius Removal Driver
In Commercial Distribution

  • 00857676008195 ()
AR-8924VD-S

  • Surgical screwdriver, single-use
SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006892 ()
1456-6565

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
5.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006885 ()
1456-5050

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Fluted surgical drill bit, single-use
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headless Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006878 ()
1456-1408

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
4.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006861 ()
1456-4040

  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Fluted surgical drill bit, single-use
  • Surgical instrument handle, non-torque-limiting
  • Surgical countersink, single-use
  • Orthopaedic intraoperative positioning pin, single-use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006854 ()
1456-3030

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Orthopaedic intraoperative positioning pin, single-use
Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
Inserter
In Commercial Distribution

  • 00850310006489 ()

  • Driver for 3.0mm CrossTIE Implant
4200-0000

  • Orthopaedic implant driver
CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.
CROSSROADS EXTREMITY SYSTEMS
Snap-Off Driver - Sterile
In Commercial Distribution

  • 00850310006410 ()
1456-0026

  • Surgical screwdriver, single-use
Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0018
In Commercial Distribution

  • 00850310006397 ()
1456-0018

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0015
In Commercial Distribution

  • 00850310006380 ()
1456-0015

  • Orthopaedic inorganic implant inserter/extractor, reusable
3.5MM HEX U-JOINT DRIVER
Conformis, Inc.
1080-561
In Commercial Distribution

  • 00850268007552 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER, RIGID, 3.5MM HEX
Conformis, Inc.
1080-560
In Commercial Distribution

  • 00850268007545 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Needle Driver
MEDROBOTICS CORPORATION
50474
In Commercial Distribution

  • 00850190004674 ()


  • Laparoscopic blunt dissector
ANCHOR BOLT DRIVER, FOR 2.4MM DRILL, DENVER DESIGN
PMT CORPORATION
2103-148
In Commercial Distribution

  • 00650551098508 ()
2103-148

  • Neurological stereotactic surgery system
sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.4MM DRILL BIT, FITTED TIP
PMT CORPORATION
2103-144
In Commercial Distribution

  • 00650551098300 ()
2103-144

  • Neurological stereotactic surgery system
sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.4MM DRILL BIT
PMT CORPORATION
2103-143
In Commercial Distribution

  • 00650551098294 ()
2103-143

  • Neurological stereotactic surgery system
sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.1MM DRILL BIT
PMT CORPORATION
2103-142
In Commercial Distribution

  • 00650551098287 ()
2103-142

  • Neurological stereotactic surgery system
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