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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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CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159008689 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159008658 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159008559 ()
9734443

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734863
In Commercial Distribution

  • 00653159007361 ()
9734863

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS/DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159007422 ()
9735231

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159007392 ()
9735218

  • Device sterilization/disinfection container, reusable
CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734444
In Commercial Distribution

  • 00653159007279 ()
9734444

  • Device sterilization/disinfection container, reusable
CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159007262 ()
9734443

  • Device sterilization/disinfection container, reusable
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
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
HEX SCREWDRIVER X0399-002 7/32 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X0399-002
In Commercial Distribution

  • 00673978135939 ()


  • Orthopaedic implant driver
MA SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0397-003
In Commercial Distribution

  • 00673978135496 ()


  • Orthopaedic implant driver
AXIS SCREWDRIVER X0295-023 11 INCH LONG
MEDTRONIC SOFAMOR DANEK, INC.
X0295-023
In Commercial Distribution

  • 00673978132280 ()


  • Orthopaedic implant driver
T-HANDLE EXT LENGTH HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-038
In Commercial Distribution

  • 00673978131788 ()


  • Orthopaedic implant driver
M8 INST C6880 FINAL PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
C6880
In Commercial Distribution

  • 00673978110998 ()


  • Orthopaedic implant driver
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