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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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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

SubQ It! Bioabsorbable Skin Closure System - 00867469000237

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable

SubQ It! Bioabsorbable Skin Closure System - 00867469000220

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable

AccuPlan System - 00864582000298

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AccuPlan System - 00864582000281

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution

  • 00864582000281 ()
MC-KTP010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory

AccuPlan System - 00864582000274

ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized

AdvantageRib - 00854865007403

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

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable

Decima Spine Instrument Kit - 00857360007107

Slap Hammer
DECIMA SPINE, INC.
6120
In Commercial Distribution

  • 00857360007107 ()
6120

  • Surgical mallet

Decima Spine Instrument Kit - 00857360007077

REMOVAL DRIVER
DECIMA SPINE, INC.
6096
In Commercial Distribution

  • 00857360007077 ()
6096

  • Surgical screwdriver, reusable

Decima Spine Instrument Kit - 00857360007053

Driver
DECIMA SPINE, INC.
6094
In Commercial Distribution

  • 00857360007053 ()
6094

  • Surgical screwdriver, reusable

MISHA® Torque Limiting Driver - 00856047005917

No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use

Explant Kit - 00855547005410

The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system

Connector Cover Kit - 00855547005397

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

  • 00855547005397 ()


  • Brain-responsive electrical stimulation system

Craniectomy Template Kit - 00855547005380

The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005380 ()


  • Brain-responsive electrical stimulation system

Ferrule Kit - 00855547005373

The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005373 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005366

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-320-K
In Commercial Distribution

  • 00855547005366 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005267

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-320-K
In Commercial Distribution

  • 00855547005267 ()


  • Brain-responsive electrical stimulation system

Burr Hole Cover - 00855547005205

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

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

Revolution External Plating System - 00854641008112

Slotted 90° Tubular Wrench x 10mm
Metalogix
900104
In Commercial Distribution

  • 00854641008112 ()

  • Slotted 90°
  • Diameter: 10mm
  • Length: 3.89 Inch


  • External orthopaedic fixation system, reusable

Revolution External Plating System - 00854641008099

General Tray
Metalogix
900127-F
In Commercial Distribution

  • 00854641008099 ()

  • Height: 10.1 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable

Revolution External Plating System - 00854641008082

Instrument + Hardware Tray
Metalogix
900126-F
In Commercial Distribution

  • 00854641008082 ()

  • Height: 5.5 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
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