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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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Reform MC Screw System - 00840019927994

Modular Screw Driver
PRECISION SPINE, INC.
59-SP-0700
In Commercial Distribution

  • 00840019927994 ()
59-SP-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform MC Screw System - 00840019927987

Adjustment Screw Driver
PRECISION SPINE, INC.
59-SP-0601
In Commercial Distribution

  • 00840019927987 ()
59-SP-0601

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ACUMED - 10806378043383

Impact Driver Handle
Acumed LLC
80-0607
In Commercial Distribution

  • 10806378043383 ()


  • Surgical instrument handle, non-torque-limiting

Reform MC Screw System - 00840019927482

Modular Screw Driver
PRECISION SPINE, INC.
59-MS-0700
In Commercial Distribution

  • 00840019927482 ()
59-MS-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926584

T15 Torque Driver
PRECISION SPINE, INC.
55-IN-0121
In Commercial Distribution

  • 00840019926584 ()
55-IN-0121

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019922203

Universal Driver 2.5mm
PRECISION SPINE, INC.
10-1003-2
In Commercial Distribution

  • 00840019922203 ()
10-1003-2

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Accufit Lateral Plate System - 00840019919852

Lock Unlock Driver
PRECISION SPINE, INC.
58-SD-0300
In Commercial Distribution

  • 00840019919852 ()
58-SD-0300

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Accufit Lateral Plate System - 00840019919845

Locking Screw Driver
PRECISION SPINE, INC.
58-SD-0200
In Commercial Distribution

  • 00840019919845 ()
58-SD-0200

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Accufit Lateral Plate System - 00840019919821

Bone Screw Driver
PRECISION SPINE, INC.
58-SD-0100
In Commercial Distribution

  • 00840019919821 ()
58-SD-0100

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Lateral Access - 00840019919517

Fixation Pin Driver
PRECISION SPINE, INC.
54-HD-0200
In Commercial Distribution

  • 00840019919517 ()
54-HD-0200

  • Neurosurgical retraction system, spinal
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