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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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Spider Cervical Plating System - M697N600002011

Sterilization Case, Spider System
Xtant Medical Holdings, Inc.
N60000201
In Commercial Distribution

  • M697N600002010 ()
  • M697N600002011 ()


  • Spinal fixation plate, non-bioabsorbable

INNOSPIRE GO Carry Case - 00383730003887

INNOSPIRE GO Carry Case
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730003887 ()
1128576

  • Ultrasonic nebulizing system

Certex Spinal Fixation System - M697X06700171

Sterilization Case Occipital Set
Xtant Medical Holdings, Inc.
X067-0017
Not in Commercial Distribution

  • M697X06700170 ()
  • M697X06700171 ()


  • Device sterilization/disinfection container, reusable

Certex Spinal Fixation System - M697X06700161

Sterilization Case Connector Set
Xtant Medical Holdings, Inc.
X067-0016
Not in Commercial Distribution

  • M697X06700160 ()
  • M697X06700161 ()


  • Device sterilization/disinfection container, reusable

Certex Spinal Fixation System - M697X06700041

Sterilization Case, Certex, Instrument
Xtant Medical Holdings, Inc.
X067-0004
Not in Commercial Distribution

  • M697X06700040 ()
  • M697X06700041 ()


  • Device sterilization/disinfection container, reusable

Certex Spinal Fixation System - M697X06700031

Sterilization Case, Certex, Implant
Xtant Medical Holdings, Inc.
X067-0003
Not in Commercial Distribution

  • M697X06700030 ()
  • M697X06700031 ()


  • Device sterilization/disinfection container, reusable

Irix-C Cervical Integrated Fusion System - M697X06600041

Instrument Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0004
In Commercial Distribution

  • M697X06600040 ()
  • M697X06600041 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X06600031

Implant Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0003
In Commercial Distribution

  • M697X06600030 ()
  • M697X06600031 ()


  • Polymeric spinal interbody fusion cage

Fortex Pedicle Screw System - M697X06401221

Sterilization Case, Fortex Reduction
Xtant Medical Holdings, Inc.
X064-0122
In Commercial Distribution

  • M697X06401220 ()
  • M697X06401221 ()


  • Device sterilization/disinfection container, reusable

Fixcet Spinal Facet Screw System - M697X06310021

Sterilization Case II, Fixcet
Xtant Medical Holdings, Inc.
X063-1002
In Commercial Distribution

  • M697X06310020 ()
  • M697X06310021 ()


  • Device sterilization/disinfection container, reusable

Axle Interspinous Fusion System - M697X06000021

Axle System Sterilization Case
Xtant Medical Holdings, Inc.
X060-0002
In Commercial Distribution

  • M697X06000020 ()
  • M697X06000021 ()


  • Lumbar interspinous decompression instrument set, reusable

Xpress Minimally Invasive Pedicle Screw System - M697X07300031

Sterilization Case, Xpress, Implant
Xtant Medical Holdings, Inc.
X073-0003
In Commercial Distribution

  • M697X07300030 ()
  • M697X07300031 ()


  • Device sterilization/disinfection container, reusable

AutoPulse NXT - 00849111003032

AutoPulse NXT Quick Case.
Zoll Circulation, Inc.
Model 200
In Commercial Distribution

  • 00849111003032 ()
8700-001018

  • Cardiac resuscitator, line-powered

MAKOPLASTY - 00848486019839

Case, THA Array Kit
MAKO SURGICAL CORP.
151231
In Commercial Distribution

  • 00848486019839 ()
151231

  • Instrument tray, reusable

MAKO - 00848486029715

CASE HIP INSTRUMENT KIT
MAKO SURGICAL CORP.
151551
In Commercial Distribution

  • 00848486029715 ()
151551

  • Instrument tray, reusable

CARDINAL HEALTH - 10888439896060

LARGE CASE CUSTOM PACK
Cardinal Health 200, LLC
SBA63LCSEI
In Commercial Distribution

  • 50888439896068 ()
  • 10888439896060 ()
SBA63LCSEI

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439896121

SMALL CASE CUSTOM PACK
Cardinal Health 200, LLC
SBA63SCSTG
In Commercial Distribution

  • 50888439896129 ()
  • 10888439896121 ()
SBA63SCSTG

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10888439863802

KIT, LOCAL HAND CASE
Cardinal Health 200, LLC
PO35HPBJB
In Commercial Distribution

  • 50888439863800 ()
  • 10888439863802 ()
PO35HPBJB

  • Orthopaedic surgical procedure kit, medicated

CARDINAL HEALTH - 10888439952735

KIT, LOCAL HAND CASE
Cardinal Health 200, LLC
PO35HPBJC
In Commercial Distribution

  • 50888439952733 ()
  • 10888439952735 ()
PO35HPBJC

  • Orthopaedic surgical procedure kit, medicated

Nucleus - 09321502024655

Cochlear Nucleus LiteWear Case
COCHLEAR LIMITED
Z327613
In Commercial Distribution

  • 09321502024655 ()
Z327613

  • Cochlear implant/auditory brainstem implant sound processor off-ear holder

Valencia Pedicle Screw System - 00843210134697

Valencia Auxillary Case Lid-Valencia
Altus Spine, LLC
908-1206
In Commercial Distribution

  • 00843210134697 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Valencia Pedicle Screw System - 00843210134642

Valencia Sterilization Case 2
Altus Spine, LLC
908-1202
In Commercial Distribution

  • 00843210134642 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Valencia Pedicle Screw System - 00843210134635

Valencia Sterilization Case 1
Altus Spine, LLC
908-1201
In Commercial Distribution

  • 00843210134635 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

BMT Medizintechnik GmbH - 04251725204365

NEEDLE CASE, 78X15 MM
BMT Medizintechnik GmbH
BS-1
In Commercial Distribution

  • 04251725204365 ()
BS-1

  • Device sterilization/disinfection container, reusable

CARDINAL HEALTH - 10888439158625

HERNIA REPAIR CASE PACK
Cardinal Health 200, LLC
SBA42HRMSD
In Commercial Distribution

  • 50888439158623 ()
  • 10888439158625 ()
SBA42HRMSD

  • General surgical procedure kit, medicated

b-ONE™ Primary Acetabular System - 00843575104182

Acetabular Reamers Sterilization Case
B-ONE ORTHO, CORP.
8819900300
In Commercial Distribution

  • 00843575104182 ()
8819900300

  • Surgical instrument/implant rack

CARDINAL HEALTH - 10888439206227

SMALL CASE CUSTOM PREFERRED
Cardinal Health 200, LLC
SBA63SCST3
In Commercial Distribution

  • 50888439206225 ()
  • 10888439206227 ()
SBA63SCST3

  • General surgical procedure kit, non-medicated, single-use

b-ONE Hip Instrumentation - 00843575124364

Half Tray Outer Case
B-ONE ORTHO, CORP.
8819910002
In Commercial Distribution

  • 00843575124364 ()
8819910002

  • Surgical instrument/implant rack

Omnia Medical VBR - 00843511100490

Omnia Medical VBR, Case
OMNIA MEDICAL, LLC
06-7V-TRA1
In Commercial Distribution

  • 00843511100490 ()
06-7V-TRA1

  • Surgical instrument interim-placement holder, reusable

Made-To-Order - 00846832099252

Bow Tie Reamer Case
TORNIER, INC.
9028049
In Commercial Distribution

  • 00846832099252 ()
9028049

  • Bone-resection orthopaedic reamer, reusable

Tornier Perform Humeral System - 00846832093663

Fracture Reamers Case Base
TORNIER, INC.
NBR10461
In Commercial Distribution

  • 00846832093663 ()
NBR10461

  • Instrument tray, reusable

Tornier Perform Humeral System - 00846832093601

Fracture JIG Case Base
TORNIER, INC.
NBR10441
In Commercial Distribution

  • 00846832093601 ()
NBR10441

  • Instrument tray, reusable

Tornier Perform Humeral System - 00846832093571

Fracture Instruments Case Base
TORNIER, INC.
NBR10411
In Commercial Distribution

  • 00846832093571 ()
NBR10411

  • Instrument tray, reusable

Tornier Simpliciti - 00846832023813

Trial Head Case Lid
TORNIER, INC.
9722916
In Commercial Distribution

  • 00846832023813 ()
9722916

  • Instrument tray, reusable

Tornier Simpliciti - 00846832023806

Trial Head Case Base
TORNIER, INC.
9722915
In Commercial Distribution

  • 00846832023806 ()
9722915

  • Instrument tray, reusable

Tornier Flex Shoulder System - 00846832020607

Humeral Instrument Case Lid
TORNIER
NCR252
In Commercial Distribution

  • 00846832020607 ()
NCR252

  • Instrument tray, reusable

Tornier Flex Shoulder System - 00846832019410

Reversed Revision Case Lid
TORNIER
NCR030
In Commercial Distribution

  • 00846832019410 ()
NCR030

  • Instrument tray, reusable

CARDINAL HEALTH - 10888439728545

SMALL CASE CUSTOM PREFERRED
Cardinal Health 200, LLC
SBA63SCST5
In Commercial Distribution

  • 50888439728543 ()
  • 10888439728545 ()
SBA63SCST5

  • General surgical procedure kit, non-medicated, single-use

Tornier Simpliciti - 00846832015948

Trial Head Case Lid
TORNIER, INC.
9722912
In Commercial Distribution

  • 00846832015948 ()
9722912

  • Instrument tray, reusable

Tornier Simpliciti - 00846832015931

Trial Head Case Base
TORNIER, INC.
9722911
In Commercial Distribution

  • 00846832015931 ()
9722911

  • Instrument tray, reusable

UTF™ Stem - 04719872179139

UTF Stem case #1
UNITED ORTHOPEDIC CORP.
9106-8010
In Commercial Distribution

  • 04719872179139 ()
9106-8010

  • Instrument tray, reusable

U2 Total Knee System - 04719872178019

U2 Knee MIS case
UNITED ORTHOPEDIC CORP.
9303-8060-RT
In Commercial Distribution

  • 04719872178019 ()
9303-8060-RT

  • Instrument tray, reusable

U2™ Knee - 04719872178002

U2 Knee XUC case
UNITED ORTHOPEDIC CORP.
9303-8053
In Commercial Distribution

  • 04719872178002 ()
9303-8053

  • Instrument tray, reusable

U2 Total Knee System - 04719872177999

U2 Knee CMA case
UNITED ORTHOPEDIC CORP.
9303-8052
In Commercial Distribution

  • 04719872177999 ()
9303-8052

  • Instrument tray, reusable

U2 Total Knee System - 04719872177982

U2 Knee case #4
UNITED ORTHOPEDIC CORP.
9303-8040-RT
In Commercial Distribution

  • 04719872177982 ()

  • #4
9303-8040-RT

  • Instrument tray, reusable

U2 Total Knee System - 04719872177975

U2 Knee case #3
UNITED ORTHOPEDIC CORP.
9303-8030-RT
In Commercial Distribution

  • 04719872177975 ()

  • #3
9303-8030-RT

  • Instrument tray, reusable

U2 Total Knee System - 04719872177968

Tibial insert trial case
UNITED ORTHOPEDIC CORP.
9303-8029
In Commercial Distribution

  • 04719872177968 ()
9303-8029

  • Instrument tray, reusable

U2 Total Knee System - 04719872177951

U2 Knee case #2
UNITED ORTHOPEDIC CORP.
9303-8020-RT
In Commercial Distribution

  • 04719872177951 ()

  • #2
9303-8020-RT

  • Instrument tray, reusable

U2 Total Knee System - 04719872177944

U2 Knee case #1
UNITED ORTHOPEDIC CORP.
9303-8010-RT
In Commercial Distribution

  • 04719872177944 ()

  • #1
9303-8010-RT

  • Instrument tray, reusable

UCP™ Stem - 04719872177845

UCP Stem case #2
UNITED ORTHOPEDIC CORP.
9107-8120
In Commercial Distribution

  • 04719872177845 ()
9107-8120

  • Instrument tray, reusable
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