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

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
Slap Hammer
DECIMA SPINE, INC.
6120
In Commercial Distribution

  • 00857360007107 ()
6120

  • Surgical mallet
REMOVAL DRIVER
DECIMA SPINE, INC.
6096
In Commercial Distribution

  • 00857360007077 ()
6096

  • Surgical screwdriver, reusable
Driver
DECIMA SPINE, INC.
6094
In Commercial Distribution

  • 00857360007053 ()
6094

  • Surgical screwdriver, reusable
No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
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
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
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
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
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
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
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
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
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
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
J/N-Plate Tray
Metalogix
900125-F
In Commercial Distribution

  • 00854641008075 ()

  • Height: 9.6 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
C/Footplate Tray
Metalogix
900124-F
In Commercial Distribution

  • 00854641008068 ()

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


  • External orthopaedic fixation system, reusable
Implant Tray
Metalogix
900123-F
In Commercial Distribution

  • 00854641008051 ()

  • Width: 10.3 Inch
  • Height: 5.8 Inch
  • Length: 20.9 Inch


  • External orthopaedic fixation system, reusable
Standard Wrench x 10mm
Metalogix
900106
In Commercial Distribution

  • 00854641008044 ()

  • Standard
  • Diameter: 10mm


  • External orthopaedic fixation system, reusable
Open End/Swivel End Wrench x 10mm
Metalogix
900105
In Commercial Distribution

  • 00854641008037 ()

  • Open End/Swivel End
  • Diameter: 10mm


  • External orthopaedic fixation system, reusable
Wire Tensioner x Ratcheting
Metalogix
900100
In Commercial Distribution

  • 00854641008020 ()


  • External orthopaedic fixation system, reusable
T-Handle Wrench x AO
Metalogix
900103
In Commercial Distribution

  • 00854641008013 ()


  • External orthopaedic fixation system, reusable
Trocar & Sheath 4-6mm
Metalogix
100404
In Commercial Distribution

  • 00854641008006 ()

  • 4-6mm


  • External orthopaedic fixation system, reusable
INSTRUMENT 876-484 LOCKSCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
876-484
In Commercial Distribution

  • 00673978070902 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 876-482
MEDTRONIC SOFAMOR DANEK, INC.
876-482
In Commercial Distribution

  • 00673978070896 ()


  • Surgical screwdriver, reusable
INSTRUMENT 876-406 PLT HOLDING PIN DRVER
MEDTRONIC SOFAMOR DANEK, INC.
876-406
In Commercial Distribution

  • 00673978070766 ()


  • Orthopaedic implant driver
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