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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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SYNAPSE - 10705034795393

SYNAPSE TRANSCONNECTOR MODULE CASE
Synthes GmbH
60.615.016
In Commercial Distribution

  • H981606150160 ()
  • 10705034795393 ()
60615016

  • Instrument tray, reusable

NA - 10705034794907

UNIVERSAL GRAPHIC CASE LID
Synthes GmbH
60.600.006
In Commercial Distribution

  • H981606000060 ()
  • 10705034794907 ()
60600006

  • Instrument tray, reusable

Reform POCT System - 00840019927154

Add-on Instrument Sterilization Case
PRECISION SPINE, INC.
55-SC-0203
In Commercial Distribution

  • 00840019927154 ()
55-SC-0203

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019927017

Occipital Instrument Sterilization Case
PRECISION SPINE, INC.
55-SC-0202
In Commercial Distribution

  • 00840019927017 ()
55-SC-0202

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019927000

Standard Instrument Sterilization Case
PRECISION SPINE, INC.
55-SC-0201
In Commercial Distribution

  • 00840019927000 ()
55-SC-0201

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926997

Occipital Implant Sterilization Case
PRECISION SPINE, INC.
55-SC-0103
In Commercial Distribution

  • 00840019926997 ()
55-SC-0103

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926980

Add-on Implant Sterilization Case
PRECISION SPINE, INC.
55-SC-0102
In Commercial Distribution

  • 00840019926980 ()
55-SC-0102

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926973

Standard Implant Sterilization Case
PRECISION SPINE, INC.
55-SC-0101
In Commercial Distribution

  • 00840019926973 ()
55-SC-0101

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Accufit Lateral Plate System - 00840019919876

AccuFit® LP Case
PRECISION SPINE, INC.
58-SC-1000
In Commercial Distribution

  • 00840019919876 ()
58-SC-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Lateral Access - 00840019919708

Light Cable Case (Empty)
PRECISION SPINE, INC.
54-SC-3000
In Commercial Distribution

  • 00840019919708 ()
54-SC-3000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Lateral Access - 00840019919692

Table Arm Case (Empty)
PRECISION SPINE, INC.
54-SC-2000
In Commercial Distribution

  • 00840019919692 ()
54-SC-2000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918893

0° Implant Case (Empty)
PRECISION SPINE, INC.
60-SC-6000
In Commercial Distribution

  • 00840019918893 ()
60-SC-6000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918862

7° Implant Case (Empty)
PRECISION SPINE, INC.
60-SC-5000
In Commercial Distribution

  • 00840019918862 ()
60-SC-5000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918855

Angled Instruments Case (Empty)
PRECISION SPINE, INC.
60-SC-4000
In Commercial Distribution

  • 00840019918855 ()
60-SC-4000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918831

Implantation Instruments Case (Empty)
PRECISION SPINE, INC.
60-SC-2000
In Commercial Distribution

  • 00840019918831 ()
60-SC-2000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918824

Cobbs / Curettes Case (Empty)
PRECISION SPINE, INC.
60-SC-1000
In Commercial Distribution

  • 00840019918824 ()
60-SC-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936538

Implant Case 2 (Complete)
PRECISION SPINE, INC.
63-8700-CA
In Commercial Distribution

  • 00840019936538 ()
63-8700-CA

  • Spinal bone screw, non-bioabsorbable
  • Bone-screw internal spinal fixation system rod
  • Spinal bone set screw

SureLOK MIS 3L - 00840019936507

Instrument Case - M (Complete)
PRECISION SPINE, INC.
63-8100-CA
In Commercial Distribution

  • 00840019936507 ()
63-8100-CA

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Vue™ Lateral Discectomy System - 00840019936354

Cobbs / Curettes Case Kit
PRECISION SPINE, INC.
60-BK-1000
In Commercial Distribution

  • 00840019936354 ()
60-BK-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928915

Instrument Sterilization Case 2
PRECISION SPINE, INC.
39-SC-0202
In Commercial Distribution

  • 00840019928915 ()
39-SC-0202

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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