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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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PMT® CORPORATION HALO - 00650551094609

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

PMT® CORPORATION HALO - 00650551094593

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

PMT® CORPORATION HALO - 00650551094586

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

PMT® CORPORATION HALO - 00650551094579

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

PMT® CORPORATION HALO - 00650551094562

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

PMT® CORPORATION HALO - 00650551094555

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

PMT® CORPORATION HALO - 00650551094548

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

PMT® CORPORATION HALO - 00650551094531

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

PMT® CORPORATION HALO - 00650551094524

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

PMT® CORPORATION HALO - 00650551094517

TRAUMA KIT, 1211-1L LARGE RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L3
In Commercial Distribution

  • 00650551094517 ()
1211-6L3

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551094500

TRAUMA KIT, 1211-1L LARGE RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L1
In Commercial Distribution

  • 00650551094500 ()
1211-6L1

  • Cervical spine immobilization system, single-use

INTREPED, Intraosseous Fusion Device - 00850055649170

INTREPED 12 Driver
Auxano Medical LLC
01-40212
In Commercial Distribution

  • 00850055649170 ()
01-40212

  • Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device - 00850055649163

INTREPED 09 Driver
Auxano Medical LLC
01-40209
In Commercial Distribution

  • 00850055649163 ()
01-40209

  • Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device - 00850055649156

INTREPED 06 Driver
Auxano Medical LLC
01-40206
In Commercial Distribution

  • 00850055649156 ()
01-40206

  • Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device - 00850055649415

INTREPED 10 Driver
Auxano Medical LLC
01-40210
In Commercial Distribution

  • 00850055649415 ()
01-40210

  • Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device - 00850055649408

INTREPED 08 Driver
Auxano Medical LLC
01-40208
In Commercial Distribution

  • 00850055649408 ()
01-40208

  • Orthopaedic bone screw (non-sliding)

SI-RESTORE - 00850073363294

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300035
In Commercial Distribution

  • 00850073363294 ()


  • Surgical screwdriver, reusable

SI-RESTORE - 00850073363270

MALLET
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300031
In Commercial Distribution

  • 00850073363270 ()


  • Surgical mallet

SI-RESTORE - 00850073363218

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300017
In Commercial Distribution

  • 00850073363218 ()


  • Surgical screwdriver, reusable

EquiLOX Lumbar Expandable Cage - Square Cage Driver (AO connector) - 00850065741253

Square Cage Driver (AO connector)
CAPTIVA SPINE, INC.
CSE06-R-0500-86
In Commercial Distribution

  • 00850065741253 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

EquiLOX Lumbar Expandable Cage - Slap Hammer (tuning fork style) - 00850065741239

Slap Hammer (tuning fork style)
CAPTIVA SPINE, INC.
CSE06-R-1000-29
In Commercial Distribution

  • 00850065741239 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Hammer power shaft - 00850065741055

Hammer power shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-26
In Commercial Distribution

  • 00850065741055 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Hammer connecting shaft - 00850065741048

Hammer connecting shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-28
In Commercial Distribution

  • 00850065741048 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Square Cage Driver - 00850065741031

Square Cage Driver
CAPTIVA SPINE, INC.
CSE06-R-0500-48
In Commercial Distribution

  • 00850065741031 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

SAM Medical - 00850068519033

SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual

PMT CORPORATION - STEREOTACTIC - 00650551098508

ANCHOR BOLT DRIVER, FOR 2.4MM DRILL, DENVER DESIGN
PMT CORPORATION
2103-148
In Commercial Distribution

  • 00650551098508 ()
2103-148

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551098300

sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.4MM DRILL BIT, FITTED TIP
PMT CORPORATION
2103-144
In Commercial Distribution

  • 00650551098300 ()
2103-144

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551098294

sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.4MM DRILL BIT
PMT CORPORATION
2103-143
In Commercial Distribution

  • 00650551098294 ()
2103-143

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551098287

sEEG DEPTH ANCHOR BOLT DRIVER, FOR 2.1MM DRILL BIT
PMT CORPORATION
2103-142
In Commercial Distribution

  • 00650551098287 ()
2103-142

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551098140

RULER, WITH SAME DIAMETER AS sEEG DRIVER, FOR 2.1MM DIAMETER DRILL BIT
PMT CORPORATION
2103-125
Not in Commercial Distribution

  • 00650551098140 ()
2103-125

  • Neurological stereotactic surgery system
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