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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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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

Intervertebral Body Fusion Device - 00840019924955

ShurFit™ ALIF Instrument Case # 3 (Empty)
PRECISION SPINE, INC.
50-0012
In Commercial Distribution

  • 00840019924955 ()
50-0012

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924948

ShurFit™ ALIF Instrument Case # 2 (Empty)
PRECISION SPINE, INC.
50-0011
In Commercial Distribution

  • 00840019924948 ()
50-0011

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019924931

ShurFit™ ALIF Instrument Case # 1 (Empty)
PRECISION SPINE, INC.
50-0010
In Commercial Distribution

  • 00840019924931 ()
50-0010

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923835

PLIF/TLIF/TPLIF Instrument Case 2 (Empty)
PRECISION SPINE, INC.
50-0024
In Commercial Distribution

  • 00840019923835 ()
50-0024

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device - 00840019923828

PLIF/TLIF/TPLIF Instrument Case 1 (Empty)
PRECISION SPINE, INC.
50-0023
In Commercial Distribution

  • 00840019923828 ()
50-0023

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Matrixx System - 00889929056349

Nexxt Matrixx Anterolateral Angled Disc Prep Case
NEXXT SPINE, LLC
C92-01-07
In Commercial Distribution

  • 00889929056349 ()


  • Device sterilization/disinfection container, reusable

Matrixx System - 00889929055700

Posterior Disc Prep Case 2 of 2
NEXXT SPINE, LLC
C92-01-04
In Commercial Distribution

  • 00889929055700 ()


  • Device sterilization/disinfection container, reusable

Matrixx System - 00889929055694

Posterior Disc Prep Case 1 of 2
NEXXT SPINE, LLC
C92-01-03
In Commercial Distribution

  • 00889929055694 ()


  • Device sterilization/disinfection container, reusable

ACUMED - 10806378089893

Acu-Loc® 2 CORE System Case Lid
Acumed LLC
80-1996
In Commercial Distribution

  • 10806378089893 ()


  • General internal orthopaedic fixation system implantation kit

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

APEX 3D S Total Ankle Replacement System - 00889795140715

Short Stem Tibia System, Instrument Case, Lid
Paragon 28, Inc.
P11-900-CASL
In Commercial Distribution

  • 00889795140715 ()
P11-900-CASL

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140708

Short Stem Tibia System, Instrument Case, Base
Paragon 28, Inc.
P11-900-CASB
In Commercial Distribution

  • 00889795140708 ()
P11-900-CASB

  • Device sterilization/disinfection container, reusable

SynMesh - 10705034799742

GRAPHIC CASE FOR CONTOURED SYNMESH(TM) SET
Synthes GmbH
690.282
In Commercial Distribution

  • H9816902820 ()
  • 10705034799742 ()
690282

  • Instrument tray, reusable

ProPrep - 10705034799469

GRAPHIC CASE FOR PROPREP(TM) INSTRUMENT SET
Synthes GmbH
690.210
In Commercial Distribution

  • H9816902100 ()
  • 10705034799469 ()
690210

  • Instrument tray, reusable

PROACCESS - 10705034799452

GRAPHIC CASE FOR PROACCESS BONE LEVER SET
Synthes GmbH
690.206
In Commercial Distribution

  • H9816902060 ()
  • 10705034799452 ()
690206

  • Instrument tray, reusable

T-PLIF - 10705034799117

GRAPHIC CASE FOR T-PLIF AUXILIARY INSTRUMENT SET
Synthes GmbH
690.125
In Commercial Distribution

  • H9816901250 ()
  • 10705034799117 ()
690125

  • Instrument tray, reusable

Veptr - 10705034799094

GRAPHIC CASE FOR VEPTR(TM) LENGTHENING SET
Synthes GmbH
690.116
In Commercial Distribution

  • H9816901160 ()
  • 10705034799094 ()
690116

  • Instrument tray, reusable

PLIF - 10705034799063

PLIF TRIAL SPACER TRAY FOR GRAPHIC CASE
Synthes GmbH
690.107
In Commercial Distribution

  • H9816901070 ()
  • 10705034799063 ()
690107

  • Instrument tray, reusable

NA - 10705034799018

GRAPHIC CASE FOR SPINE SCREW REMOVAL SET
Synthes GmbH
690.099
In Commercial Distribution

  • H9816900990 ()
  • 10705034799018 ()
690099

  • Instrument tray, reusable

Veptr - 10705034798950

GRAPHIC CASE FOR VEPTR BASIC INSTRUMENT SET
SYNTHES (U.S.A.) LP
690.088
In Commercial Distribution

  • 07611819758391 ()
  • H9816900880 ()
  • 10705034798950 ()
690088

  • Instrument tray, reusable

USS - 10705034798547

DUAL-OPENING USS SCREW IMPLANT SET GRAPHIC CASE
Synthes GmbH
690.046
In Commercial Distribution

  • H9816900460 ()
  • 10705034798547 ()
690046

  • Instrument tray, reusable

USS - 10705034798516

DUAL-OPENING USS ROD INSTRUMENT SET GRAPHIC CASE
Synthes GmbH
690.043
In Commercial Distribution

  • H9816900430 ()
  • 10705034798516 ()
690043

  • Instrument tray, reusable

ACF - 10705034798394

ANTERIOR CERVICAL FUSION INSTRUMENT SET GRAPHIC CASE
Synthes GmbH
690.030
In Commercial Distribution

  • H9816900300 ()
  • 10705034798394 ()
690030

  • Instrument tray, reusable
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