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

  • 04711605582766 ()
9107-8120-RA

  • Instrument tray, reusable
Hip stem basic case
UNITED ORTHOPEDIC CORP.
9110-8102
In Commercial Distribution

  • 04711605587082 ()
9110-8102

  • Instrument tray, reusable
Hip stem basic case
UNITED ORTHOPEDIC CORP.
9106-8702
In Commercial Distribution

  • 04711605585330 ()
9106-8702

  • Instrument tray, reusable
INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

  • 00846468020842 ()


  • General internal orthopaedic fixation system implantation kit
TRIPLE LAYER CASE BASE
Pioneer Surgical Technology, Inc.
02-CASE-TLBASE
Not in Commercial Distribution

  • 00846468006846 ()
02-CASE-TLBASE

  • Device sterilization/disinfection container, reusable
DOUBLE LAYER CASE BASE
Pioneer Surgical Technology, Inc.
02-CASE-DLBASE
Not in Commercial Distribution

  • 00846468006747 ()
02-CASE-DLBASE

  • Device sterilization/disinfection container, reusable
STERILIZATION CASE, 3.5mm/ 4.0mm
Pioneer Surgical Technology, Inc.
00-1147-035-01
In Commercial Distribution

  • 00846468073992 ()
00-1147-035-01

  • Device sterilization/disinfection container, reusable
INSTRUMENT CASE 2, EMPTY
Pioneer Surgical Technology, Inc.
04-SLMIS-INS-2-EMP
Not in Commercial Distribution

  • 00846468064143 ()
04-SLMIS-INS-2-EMP

  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE 1, EMPTY
Pioneer Surgical Technology, Inc.
04-SLMIS-INS-1-EMP
Not in Commercial Distribution

  • 00846468064136 ()
04-SLMIS-INS-1-EMP

  • General internal orthopaedic fixation system implantation kit
Axle System Sterilization Case
Xtant Medical Holdings, Inc.
X060-0002
In Commercial Distribution

  • M697X06000020 ()
  • M697X06000021 ()


  • Lumbar interspinous decompression instrument set, reusable
Sterilization Case Occipital Set
Xtant Medical Holdings, Inc.
X067-0017
Not in Commercial Distribution

  • M697X06700170 ()
  • M697X06700171 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case Connector Set
Xtant Medical Holdings, Inc.
X067-0016
Not in Commercial Distribution

  • M697X06700160 ()
  • M697X06700161 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Certex, Instrument
Xtant Medical Holdings, Inc.
X067-0004
Not in Commercial Distribution

  • M697X06700040 ()
  • M697X06700041 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Certex, Implant
Xtant Medical Holdings, Inc.
X067-0003
Not in Commercial Distribution

  • M697X06700030 ()
  • M697X06700031 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case II, Fixcet
Xtant Medical Holdings, Inc.
X063-1002
In Commercial Distribution

  • M697X06310020 ()
  • M697X06310021 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Xpress, Implant
Xtant Medical Holdings, Inc.
X073-0003
In Commercial Distribution

  • M697X07300030 ()
  • M697X07300031 ()


  • Device sterilization/disinfection container, reusable
Instrument Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0004
In Commercial Distribution

  • M697X06600040 ()
  • M697X06600041 ()


  • Polymeric spinal interbody fusion cage
Implant Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0003
In Commercial Distribution

  • M697X06600030 ()
  • M697X06600031 ()


  • Polymeric spinal interbody fusion cage
Sterilization Case, Fortex Reduction
Xtant Medical Holdings, Inc.
X064-0122
In Commercial Distribution

  • M697X06401220 ()
  • M697X06401221 ()


  • Device sterilization/disinfection container, reusable
INNOSPIRE GO Carry Case
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730003887 ()
1128576

  • Ultrasonic nebulizing system
Sterilization Case Atrix-C Instruments
Xtant Medical Holdings, Inc.
X094-0005
In Commercial Distribution

  • M697X09400050 ()
  • M697X09400051 ()


  • Cadaveric-donor bone allograft
Xsert Instrument Sterilization Case
Xtant Medical Holdings, Inc.
X092-0005
Not in Commercial Distribution

  • M697X09200050 ()
  • M697X09200051 ()


  • Metallic spinal interbody fusion cage
STERILIZATION CASE, PRIMARY, ARANAX
Xtant Medical Holdings, Inc.
X086-0004
In Commercial Distribution

  • M697X08600040 ()
  • M697X08600041 ()


  • Spinal fixation plate, non-bioabsorbable
Aranax System Carrying Case
Xtant Medical Holdings, Inc.
X086-0002
In Commercial Distribution

  • M697X08600021 ()


  • Spinal fixation plate, non-bioabsorbable
Sterilization Case, X90, Instrument
Xtant Medical Holdings, Inc.
N60002103
In Commercial Distribution

  • M697N600021030 ()
  • M697N600021031 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, X90, Implant
Xtant Medical Holdings, Inc.
N60002102
In Commercial Distribution

  • M697N600021020 ()
  • M697N600021021 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Spider System
Xtant Medical Holdings, Inc.
N60000201
In Commercial Distribution

  • M697N600002010 ()
  • M697N600002011 ()


  • Spinal fixation plate, non-bioabsorbable
ISIS Xpress empty case
inomed Medizintechnik GmbH
504106
In Commercial Distribution

  • 04250307607303 ()


  • Nerve-function monitor
Sterilization Case, Fortex, Instrument
Xtant Medical Holdings, Inc.
X022-0195
In Commercial Distribution

  • M697X02201950 ()
  • M697X02201951 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, Fortex, Implant
Xtant Medical Holdings, Inc.
X022-0194
In Commercial Distribution

  • M697X02201940 ()
  • M697X02201941 ()


  • Device sterilization/disinfection container, reusable
Sterilization Case, ButreX System
Xtant Medical Holdings, Inc.
X023-0200
Not in Commercial Distribution

  • M697X02302000 ()
  • M697X02302001 ()


  • Spinal fixation plate, non-bioabsorbable
85 Screw Case Cover
L&K BIOMED CO. ,LTD.
LS03-8011
In Commercial Distribution

  • 08809986460837 ()
LS03-8011

  • Orthopaedic prosthesis implantation positioning instrument, reusable
65 Screw Case Cover
L&K BIOMED CO. ,LTD.
LS03-8010
In Commercial Distribution

  • 08809986460820 ()
LS03-8010

  • Orthopaedic prosthesis implantation positioning instrument, reusable
55 Screw Case Cover
L&K BIOMED CO. ,LTD.
LS03-8009
In Commercial Distribution

  • 08809986460813 ()
LS03-8009

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Implant Case - Caddy (removal)
L&K BIOMED CO. ,LTD.
PB05-8008
In Commercial Distribution

  • 08809986460509 ()
PB05-8008

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Basic Instrument Case - Container
L&K BIOMED CO. ,LTD.
PB05-1002
In Commercial Distribution

  • 08809986460394 ()
PB05-1002

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Basic Instrument Case - Cover
L&K BIOMED CO. ,LTD.
PB05-1001
In Commercial Distribution

  • 08809986460387 ()
PB05-1001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SMALL CASE CUSTOM PREFERRED
Cardinal Health 200, LLC
SBA63SCST3
In Commercial Distribution

  • 50888439206225 ()
  • 10888439206227 ()
SBA63SCST3

  • General surgical procedure kit, non-medicated, single-use
ExtremiLOCK Ankle Case, Reduced
OSTEOMED LLC
320-2940
In Commercial Distribution

  • 00845694090780 ()
320-2940

  • General internal orthopaedic fixation system implantation kit
ExtremiLOCK Ankle Module Case
OSTEOMED LLC
320-2931
In Commercial Distribution

  • 00845694090773 ()
320-2931

  • General internal orthopaedic fixation system implantation kit
ExtremiLOCK Ankle Fracture Case
OSTEOMED LLC
320-2930
In Commercial Distribution

  • 00845694090766 ()
320-2930

  • General internal orthopaedic fixation system implantation kit
CASE 6970018 6X18 INSTRUMENTS
MEDTRONIC SOFAMOR DANEK, INC.
6970018
In Commercial Distribution

  • 00613994730046 ()


  • Instrument tray, reusable
CASE 6970009 NEW INSERTERS
MEDTRONIC SOFAMOR DANEK, INC.
6970009
In Commercial Distribution

  • 00613994730039 ()


  • Instrument tray, reusable
Case, Empty, ICON Set
OSTEOMED LLC
220-0801
In Commercial Distribution

  • 00845694060806 ()
220-0801

  • General internal orthopaedic fixation system implantation kit
Case Base, ICON Set
OSTEOMED LLC
220-0801-00
In Commercial Distribution

  • 00845694058322 ()
220-0801-00

  • General internal orthopaedic fixation system implantation kit
Acetabular Reamers Sterilization Case
B-ONE ORTHO, CORP.
8819900300
In Commercial Distribution

  • 00843575104182 ()
8819900300

  • Surgical instrument/implant rack
Half Tray Outer Case
B-ONE ORTHO, CORP.
8819910002
In Commercial Distribution

  • 00843575124364 ()
8819910002

  • Surgical instrument/implant rack
NEEDLE CASE, 78X15 MM
BMT Medizintechnik GmbH
BS-1
In Commercial Distribution

  • 04251725204365 ()
BS-1

  • Device sterilization/disinfection container, reusable
Omnia Medical VBR, Case
OMNIA MEDICAL, LLC
06-7V-TRA1
In Commercial Distribution

  • 00843511100490 ()
06-7V-TRA1

  • Surgical instrument interim-placement holder, reusable
Valencia Auxillary Case Lid-Valencia
Altus Spine, LLC
908-1206
In Commercial Distribution

  • 00843210134697 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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