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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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Ferrule Kit - 00855547005175

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

Craniectomy Template Kit - 00855547005168

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

Connector Cover Kit - 00855547005151

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

RNS® Neurostimulator Kit - 00855547005120

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

iFuse Granite Implant System - 00855369008705

Guidewire Driver
Si-Bone Inc.
501323
In Commercial Distribution

  • 00855369008705 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Torx Driver - 00855369008699

Torx Driver
Si-Bone Inc.
501243
In Commercial Distribution

  • 00855369008699 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Nav Adapter - Driver - 00855369008682

Nav Adapter - Driver
Si-Bone Inc.
400291
In Commercial Distribution

  • 00855369008682 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

iFuse TORQ Implant System-Driver Sleeve 1 - 00855369008521

Driver Sleeve 1
Si-Bone Inc.
400248
In Commercial Distribution

  • 00855369008521 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

iFuse TORQ Implant System-Driver Sleeve 2 - 00855369008514

Driver Sleeve 2
Si-Bone Inc.
400262
In Commercial Distribution

  • 00855369008514 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Torx Driver, Cannulated - 00855369008484

Torx Driver, Cannulated
Si-Bone Inc.
501129
In Commercial Distribution

  • 00855369008484 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

AdvantageRib - 00854865007403

AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable

ClearPoint - 00850359007584

SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system

CrossRoads Screw System - 00850310006892

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

CrossRoads Screw System - 00850310006885

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

CrossRoads Screw System - 00850310006878

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

CrossRoads Screw System - 00850310006861

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

CrossRoads Screw System - 00850310006854

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

CrossTIE™ - 00850310006489

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 - 00850310006410

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

CrossTIE™ 2.0mm Hex Driver Cannulated - 00850310006397

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

CrossTIE™ H10 Driver Cannulated - 00850310006380

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

Conformis Hip System - 00850268007552

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

Conformis Hip System - 00850268007545

DRIVER, RIGID, 3.5MM HEX
Conformis, Inc.
1080-560
In Commercial Distribution

  • 00850268007545 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

PMT® CORPORATION HALO - 00650551094616

TRAUMA KIT, 1211-1X X-LARGE RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6X4
In Commercial Distribution

  • 00650551094616 ()
1211-6X4

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094609

TRAUMA KIT, 1211-1X X-LARGE RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6X3
In Commercial Distribution

  • 00650551094609 ()
1211-6X3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094593

TRAUMA KIT, 1211-1X X-LARGE RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6X1
In Commercial Distribution

  • 00650551094593 ()
1211-6X1

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094586

TRAUMA KIT, 1211-1S SMALL RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6S4
In Commercial Distribution

  • 00650551094586 ()
1211-6S4

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094579

TRAUMA KIT, 1211-1S SMALL RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6S3
In Commercial Distribution

  • 00650551094579 ()
1211-6S3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094562

TRAUMA KIT, 1211-1S SMALL RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6S1
In Commercial Distribution

  • 00650551094562 ()
1211-6S1

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094555

TRAUMA KIT, 1211-1M MEDIUM RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6M4
In Commercial Distribution

  • 00650551094555 ()
1211-6M4

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094548

TRAUMA KIT, 1211-1M MEDIUM RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6M3
In Commercial Distribution

  • 00650551094548 ()
1211-6M3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094531

TRAUMA KIT, 1211-1M MEDIUM RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6M1
In Commercial Distribution

  • 00650551094531 ()
1211-6M1

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094524

TRAUMA KIT, 1211-1L LARGE RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L4
In Commercial Distribution

  • 00650551094524 ()
1211-6L4

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094517

TRAUMA KIT, 1211-1L LARGE RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L3
In Commercial Distribution

  • 00650551094517 ()
1211-6L3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094500

TRAUMA KIT, 1211-1L LARGE RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L1
In Commercial Distribution

  • 00650551094500 ()
1211-6L1

  • Cervical spine immobilization system, single-use

PMT CORPORATION - STEREOTACTIC - 00650551098508

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

  • 00650551098508 ()
2103-148

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551098300

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

PMT CORPORATION - STEREOTACTIC - 00650551098140

RULER, WITH SAME DIAMETER AS sEEG DRIVER, FOR 2.1MM DIAMETER DRILL BIT
PMT CORPORATION
2103-125
Not in Commercial Distribution

  • 00650551098140 ()
2103-125

  • Neurological stereotactic surgery system

Flex - 00850190004674

Needle Driver
MEDROBOTICS CORPORATION
50474
In Commercial Distribution

  • 00850190004674 ()


  • Laparoscopic blunt dissector

PMT CORPORATION - STEREOTACTIC - 00650551098294

sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.4MM DRILL BIT
PMT CORPORATION
2103-143
In Commercial Distribution

  • 00650551098294 ()
2103-143

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551098287

sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.1MM DRILL BIT
PMT CORPORATION
2103-142
In Commercial Distribution

  • 00650551098287 ()
2103-142

  • Neurological stereotactic surgery system

PMT® CORPORATION HALO - 00650551094753

TRAUMA KIT, 1211-1B X-SMALL RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6B4
In Commercial Distribution

  • 00650551094753 ()
1211-6B4

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094746

TRAUMA KIT, 1211-1B X-SMALL RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6B3
In Commercial Distribution

  • 00650551094746 ()
1211-6B3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094739

TRAUMA KIT, 1211-1B X-SMALL RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6B1
In Commercial Distribution

  • 00650551094739 ()
1211-6B1

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094722

TRAUMA KIT, 1211-1A XX-SMALL RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6A4
In Commercial Distribution

  • 00650551094722 ()
1211-6A4

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094715

TRAUMA KIT, 1211-1A XX-SMALL RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6A3
In Commercial Distribution

  • 00650551094715 ()
1211-6A3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094708

TRAUMA KIT, 1211-1A XX-SMALL RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6A1
In Commercial Distribution

  • 00650551094708 ()
1211-6A1

  • Cervical spine immobilization system, single-use

Zimmer Biomet Atlas Pro Driver - 00856482008436

No Description
PRO-DEX, INC.
APD-1000-4
In Commercial Distribution

  • 00856482008436 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Pro-Dex Surgical Driver Custom Collet - 00856482008290

No Description
PRO-DEX, INC.
PDSD-5000-5
In Commercial Distribution

  • 00856482008290 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Sterilization Case, PDCMF (AXS™ NEURO DRIVER Storage and Transport Tray) - 00856482008276

No Description
PRO-DEX, INC.
PDCMF-SC-001
In Commercial Distribution

  • 00856482008276 ()


  • Device sterilization/disinfection container, reusable
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