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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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General Instrument - 00841132127223

Provisional Set Screw Driver, Band-Loc
ORTHOPEDIATRICS CORP.
01-1102-1051
In Commercial Distribution

  • 00841132127223 ()
01-1102-1051

  • Surgical screwdriver, reusable

General Instrument - 00841132126851

3.5 Hex Screwdriver with Holding Sleeve
ORTHOPEDIATRICS CORP.
01-1050-0038
In Commercial Distribution

  • 00841132126851 ()
01-1050-0038

  • Surgical screwdriver, reusable

General Instrument - 00841132126059

Large Set Screw Driver
ORTHOPEDIATRICS CORP.
01-1003-9130
In Commercial Distribution

  • 00841132126059 ()
01-1003-9130

  • Surgical screwdriver, reusable

PediFlex Advanced - 00841132145630

SLOTTED MALLET
ORTHOPEDIATRICS CORP.
01-1001-0016
In Commercial Distribution

  • 00841132145630 ()
01-1001-0016

  • Surgical mallet

General Instrument - 00841132127995

Torque Limiting Driver 95 in-lbs.
ORTHOPEDIATRICS CORP.
01-1300-0026
In Commercial Distribution

  • 00841132127995 ()
01-1300-0026

  • Surgical screwdriver, reusable

OrthoPediatrics PediFoot Deformity Correction System - 00841132159408

T7 Solid Driver, Retaining
ORTHOPEDIATRICS CORP.
01-1007-0036
In Commercial Distribution

  • 00841132159408 ()
01-1007-0036

  • Surgical screwdriver, reusable

Angled Driver - 00810017914159

Angled Driver
ELEVATION SPINE, INC.
CI-ANG-DRIVER
In Commercial Distribution

  • 00810017914159 ()
CI-ANG-DRIVER

  • Internal spinal fixation procedure kit, single-use

Spike Driver, 10mm - 00810017913565

Spike Driver, 10mm
ELEVATION SPINE, INC.
CI-DRIVER3-SP-10
In Commercial Distribution

  • 00810017913565 ()
CI-DRIVER3-SP-10

  • Internal spinal fixation procedure kit, single-use

Spike Driver, 8-9mm - 00810017913558

Spike Driver, 8-9mm
ELEVATION SPINE, INC.
CI-DRIVER3-SP-89
In Commercial Distribution

  • 00810017913558 ()
CI-DRIVER3-SP-89

  • Internal spinal fixation procedure kit, single-use

Spike Driver, 5-7mm - 00810017913541

Spike Driver, 5-7mm
ELEVATION SPINE, INC.
CI-DRIVER3-SP-567
In Commercial Distribution

  • 00810017913541 ()
CI-DRIVER3-SP-567

  • Internal spinal fixation procedure kit, single-use
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