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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No Description
PRO-DEX, INC.
APD-SC-003
In Commercial Distribution

  • 00856482008184 ()


  • Device sterilization/disinfection container, reusable
Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument.
INTEGRATED ORBITAL IMPLANTS INC
I00057
In Commercial Distribution

  • 00854066006236 ()


  • Surgical screwdriver, reusable
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
No Description
Unique Surgical
Ball Joint, Bayonet Connector
In Commercial Distribution

  • 00854515008538 ()


  • Drilling power tool attachment, basic
No Description
Unique Surgical
90 Degree, Bayonet Connector
In Commercial Distribution

  • 00854515008422 ()


  • Drilling power tool attachment, basic
No Description
Unique Surgical
45 Degree, Bayonet Connector
In Commercial Distribution

  • 00854515008415 ()


  • Drilling power tool attachment, basic
AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
CONTAINER 9735231 LEGACY TAPS / DRIVERS
Case Medical Inc.
9735231
In Commercial Distribution

  • 00653159011795 ()
9735231

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

  • 00653159011764 ()
9735218

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

  • 00653159011733 ()
9734863

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

  • 00653159010545 ()
9735231

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

  • 00653159010514 ()
9735218

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

  • 00653159010491 ()
9734863

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

  • 00653159008719 ()
9735231

  • Device sterilization/disinfection container, reusable
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
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