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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LEKSELL-sEEG DRIVER UPPER GUIDE BUSHING, FOR 2.4MM DRILL
PMT CORPORATION
2103-107
In Commercial Distribution

  • 00650551038740 ()
2103-107

  • Neurological stereotactic surgery system
ANCHOR BOLT DRIVER, FOR VERTEK AND BRAINLAB
PMT CORPORATION
2103-102
In Commercial Distribution

  • 00650551038696 ()
2103-102

  • Neurological stereotactic surgery system
VERTEK-sEEG DRIVER BUSHING, FOR 2.1MM DRILL
PMT CORPORATION
2103-03
In Commercial Distribution

  • 00650551038597 ()
2103-03

  • Neurological stereotactic surgery system
HOLO SL Reduction Driver Lock Tube
Surgalign Spine Technologies, Inc.
154000150
In Commercial Distribution

  • 00850028694701 ()


  • Surgical screwdriver, reusable
HOLO Streamline Driver, Lock Tube
Surgalign Spine Technologies, Inc.
154000140
In Commercial Distribution

  • 00850028694688 ()


  • Surgical screwdriver, reusable
HOLO Streamline Driver, Solid
Surgalign Spine Technologies, Inc.
154000130
In Commercial Distribution

  • 00850028694664 ()


  • Surgical screwdriver, reusable
MIS Driver
Fusion Robotics, LLC
1061
In Commercial Distribution

  • 00850026574500 ()
1061

  • Surgical screwdriver, reusable
Driver
Fusion Robotics, LLC
1060
In Commercial Distribution

  • 00850026574234 ()


  • Surgical screwdriver, reusable
GLOBUS EXCELSIUS GPS DRIVER BUSHING FOR 2.7MM AND 3.2MM DRILL, OVERALL LENGTH 46.5MM
PMT CORPORATION
2103-229
In Commercial Distribution

  • 00650551004905 ()


  • Neurological stereotactic surgery system
sEEG ANCHOR BOLT DRIVER for 2.2/2.4mm, Length 235mm
PMT CORPORATION
2103-236
In Commercial Distribution

  • 00650551004431 ()


  • Neurological stereotactic surgery system
TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" SKULL PINS, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6SS1
In Commercial Distribution

  • 00650551003861 ()


  • Cervical spine immobilization system, single-use
Globus Excelsius GPS Driver Bushing for 2.7 / 3.2mm DrilL
PMT CORPORATION
2103-233
In Commercial Distribution

  • 00650551003496 ()


  • Neurological stereotactic surgery system
AUTOGUIDE BUSHING, 2.2MM DRILL, DRIVER
PMT CORPORATION
2103-221
In Commercial Distribution

  • 00650551002673 ()


  • Neurological stereotactic surgery system
DRIVER EX0317005 T8
MEDTRONIC SOFAMOR DANEK, INC.
EX0317005
In Commercial Distribution

  • 00643169980662 ()


  • Surgical screwdriver, reusable
DRIVER EX0317004 T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0317004
In Commercial Distribution

  • 00643169980655 ()


  • Surgical screwdriver, reusable
ATHERECTOMY H1-14550 CUTTER DRIVER UNI
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169968554 ()


  • Mechanical atherectomy system catheter, peripheral
DRIVER X0715098 TWISTED T-25 W/ HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0715098
In Commercial Distribution

  • 00643169966604 ()


  • Surgical screwdriver, reusable
SLEEVE EX1216071 2.5 HEX SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1216071
In Commercial Distribution

  • 00643169966598 ()


  • Surgical implant/trial-implant/sizer holder, reusable
SLEEVE EX0217044 2.5 HEX SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0217044
In Commercial Distribution

  • 00643169966581 ()


  • Surgical implant/trial-implant/sizer holder, reusable
HOLO Streamline Driver, Open Cannulated
Surgalign Spine Technologies, Inc.
154000131
In Commercial Distribution

  • 00850028694671 ()


  • Surgical screwdriver, reusable
HOLO Hex Driver, Sterile
Surgalign Spine Technologies, Inc.
154000056
In Commercial Distribution

  • 00850028694121 ()


  • Multi-purpose stereotactic surgery system
Streamline MIS Driver, Nav
Surgalign Spine Technologies, Inc.
154000028
In Commercial Distribution

  • 00850028694114 ()


  • Surgical screwdriver, reusable
8mm Hex Driver, Reference Arm
Fusion Robotics, LLC
1066
In Commercial Distribution

  • 00850026574258 ()


  • Surgical screwdriver, reusable
No Description
RESOUNDANT, INC.
REFDAUX
In Commercial Distribution

  • 00850011790229 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001
In Commercial Distribution

  • 00850011790168 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESYS4001-RESYSAB
In Commercial Distribution

  • 00850011790151 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REPD2000
In Commercial Distribution

  • 00850011790106 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFPDS19
In Commercial Distribution

  • 00850011790052 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
REFPDL18
In Commercial Distribution

  • 00850011790045 ()


  • Magnetic resonance elastography acoustic driver
No Description
RESOUNDANT, INC.
RESY3002-RESYSAB
In Commercial Distribution

  • 00850011790021 ()


  • Magnetic resonance elastography acoustic driver
Instrument, Expansion Screwdriver, Long
SPINESOURCE INC
097
In Commercial Distribution

  • 00850011324097 ()
SD-4100

  • Surgical screwdriver, reusable
SF M6 Bolt Driver
Clearpoint Neuro, Inc.
NGS-BD-M6
In Commercial Distribution

  • 00850359007584 ()
NGS-BD-M6

  • Neurological stereotactic surgery system
Auxiliary Driver
SAIL FUSION, LLC
90-JFB-301100
In Commercial Distribution

  • 00850053568510 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Threaded Driver
DUNAMIS MEDICAL, LLC
1001610
In Commercial Distribution

  • 00850052601157 ()
1001610

  • Orthopaedic fixation suture button
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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