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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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SureLOK MIS 3L - 00840019936606

Implant Case 1 BOM (Center Load Rod)
PRECISION SPINE, INC.
63-8600-CA-01
In Commercial Distribution

  • 00840019936606 ()
63-8600-CA-01

  • Bone-screw internal spinal fixation system rod

SureLOK MIS 3L - 00840019936590

Instrument Case BOM (Side Load Rod Inserter)
PRECISION SPINE, INC.
63-8300-CA-02
In Commercial Distribution

  • 00840019936590 ()
63-8300-CA-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936583

Instrument Case BOM (Center Load Rod Inserter)
PRECISION SPINE, INC.
63-8300-CA-01
In Commercial Distribution

  • 00840019936583 ()
63-8300-CA-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936576

Instrument Case BOM (Side Load Rod Inserter)
PRECISION SPINE, INC.
63-8200-CA-02
In Commercial Distribution

  • 00840019936576 ()
63-8200-CA-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936569

Instrument Case BOM (Center Load Rod Inserter)
PRECISION SPINE, INC.
63-8200-CA-01
In Commercial Distribution

  • 00840019936569 ()
63-8200-CA-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936552

Instrument Case BOM (Side Load Rod Inserter)
PRECISION SPINE, INC.
63-8100-CA-02
In Commercial Distribution

  • 00840019936552 ()
63-8100-CA-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019936545

Instrument Case BOM (Center Load Rod Inserter)
PRECISION SPINE, INC.
63-8100-CA-01
In Commercial Distribution

  • 00840019936545 ()
63-8100-CA-01

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Ti Modular - 00840019935685

Reform Ti Tower Screw Implant Case BOM
PRECISION SPINE, INC.
39-BK-0530
In Commercial Distribution

  • 00840019935685 ()
39-BK-0530

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ACUMED - 10806378076220

Foot & Ankle Cong Plt Instr Module Case
Acumed LLC
PL-FAM31
In Commercial Distribution

  • 10806378076220 ()


  • Orthopaedic fixation plate, non-bioabsorbable

ACUMED - 10806378076190

Open Plate Module for Foot & Ankle Case
Acumed LLC
PL-FAM13
In Commercial Distribution

  • 10806378076190 ()


  • Orthopaedic fixation plate, non-bioabsorbable

Navigated Instrument System - 00840019970556

S-COMP Reform® POCT Navigated Instrument Case
PRECISION SPINE, INC.
76-SC-0100
In Commercial Distribution

  • 00840019970556 ()
76-SC-0100

  • Orthopaedic surgical procedure kit, non-medicated, reusable

AllCare - 00182921000496

UNIVERSAL PILLOW CASE, 21" x 30", WHITE
ALLCARE, INC
PL100
In Commercial Distribution

  • 10182921000493 ()
  • 00182921000496 ()
PL100

  • Basic pillowcase, reusable

Reform Pedicle Screw System - 00840019929080

Reform® Modular Pedicle Screw Implant Case
PRECISION SPINE, INC.
39-SC-0500
In Commercial Distribution

  • 00840019929080 ()
39-SC-0500

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Max ULIF - 00840019926218

MD-Max™ Pedicle Screw System Case - Empty
PRECISION SPINE, INC.
43-8700
In Commercial Distribution

  • 00840019926218 ()
43-8700

  • Instrument tray, reusable

MD-Max ULIF - 00840019926164

MD-Max™ ULIF Retractor Instrument Case - Empty
PRECISION SPINE, INC.
43-8050
In Commercial Distribution

  • 00840019926164 ()
43-8050

  • Instrument tray, reusable

ShurFit MALIF System - 00840019925495

ShurFit™ MALIF Instrument Case # 2 (Empty)
PRECISION SPINE, INC.
50-0015
In Commercial Distribution

  • 00840019925495 ()
50-0015

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ShurFit MALIF System - 00840019925488

ShurFit™ MALIF Instrument Case # 1 (Empty)
PRECISION SPINE, INC.
50-0014
In Commercial Distribution

  • 00840019925488 ()
50-0014

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924986

ShurFit™ ALIF Implant Case # 3 (Empty)
PRECISION SPINE, INC.
50-0021
In Commercial Distribution

  • 00840019924986 ()
50-0021

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924979

ShurFit™ ALIF Implant Case # 2 (Empty)
PRECISION SPINE, INC.
50-0020
In Commercial Distribution

  • 00840019924979 ()
50-0020

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924962

ShurFit™ ALIF Implant Case # 1 (Empty)
PRECISION SPINE, INC.
50-0019
In Commercial Distribution

  • 00840019924962 ()
50-0019

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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