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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DFOS 2 LEVEL CASE
ORTHOPEDIATRICS CORP.
01-1050-9100
In Commercial Distribution

  • 00841132132371 ()
01-1050-9100

  • Orthopaedic surgical procedure kit, non-medicated, reusable
COUPLE DEROTATION CASE 6
ORTHOPEDIATRICS CORP.
01-1003-8509
In Commercial Distribution

  • 00841132128909 ()
01-1003-8509

  • Instrument tray, reusable
IMPLANT INSTRUMENT CASE 1
ORTHOPEDIATRICS CORP.
01-1003-8504
In Commercial Distribution

  • 00841132128855 ()
01-1003-8504

  • Instrument tray, reusable
Infant LPF Case Lid
ORTHOPEDIATRICS CORP.
01-0907-0099
In Commercial Distribution

  • 00841132124659 ()
01-0907-0099

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Aileron Implant/Instrument Case
Life Spine, Inc.
114-096
In Commercial Distribution

  • 00190837043544 ()
114-096

  • Interspinous spinal fixation implant
Dyna-Link Sterilization Case - Implants
Life Spine, Inc.
114-077
In Commercial Distribution

  • 00190837041564 ()
114-077

  • Polymeric spinal interbody fusion cage
Dyna-Link Sterilization Case - Instruments
Life Spine, Inc.
114-076
In Commercial Distribution

  • 00190837041557 ()
114-076

  • Polymeric spinal interbody fusion cage
Black Widow Tray Case
SPINAL ELEMENTS
OBWID001
In Commercial Distribution

  • 00840916135188 ()


  • Device sterilization/disinfection container, reusable
INTRAFIX Advance Sterilization Case
Medos International Sàrl
254839
In Commercial Distribution

  • 10886705027637 ()
254839

  • Instrument tray, reusable
PEDIPLATE LP CASE & TRAYS
ORTHOPEDIATRICS CORP.
01-1010-902
Not in Commercial Distribution

  • 00841132135860 ()
01-1010-902

  • Orthopaedic surgical procedure kit, non-medicated, reusable
PEDIPLATE II STERILIZATION CASE
ORTHOPEDIATRICS CORP.
01-1010-602
Not in Commercial Distribution

  • 00841132135808 ()
01-1010-602

  • Orthopaedic surgical procedure kit, non-medicated, reusable
PEDIPLATE DELTA CASE LID
ORTHOPEDIATRICS CORP.
01-1010-0612
In Commercial Distribution

  • 00841132135761 ()
01-1010-0612

  • Instrument tray, reusable
3.0/3.5 CASE LID
ORTHOPEDIATRICS CORP.
01-1071-231
In Commercial Distribution

  • 00841132134481 ()
01-1071-231

  • Orthopaedic surgical procedure kit, non-medicated, reusable
3.0/3.5 CASE BOTTOM
ORTHOPEDIATRICS CORP.
01-1071-230
In Commercial Distribution

  • 00841132134474 ()
01-1071-230

  • Orthopaedic surgical procedure kit, non-medicated, reusable
4.5 MM CASE LID
ORTHOPEDIATRICS CORP.
01-1050-4004
In Commercial Distribution

  • 00841132134245 ()
01-1050-4004

  • Instrument tray, reusable
4.5 MM CASE SHELL
ORTHOPEDIATRICS CORP.
01-1050-4001
In Commercial Distribution

  • 00841132134214 ()
01-1050-4001

  • Instrument tray, reusable
4.5 MM CASE COMPLETE
ORTHOPEDIATRICS CORP.
01-1050-4000
In Commercial Distribution

  • 00841132134207 ()
01-1050-4000

  • Instrument tray, reusable
3.5 MM CASE LID
ORTHOPEDIATRICS CORP.
01-1050-3003
In Commercial Distribution

  • 00841132134177 ()
01-1050-3003

  • Instrument tray, reusable
3.5 MM CASE SHELL
ORTHOPEDIATRICS CORP.
01-1050-3001
In Commercial Distribution

  • 00841132134153 ()
01-1050-3001

  • Instrument tray, reusable
3.5 MM CASE COMPLETE
ORTHOPEDIATRICS CORP.
01-1050-3000
In Commercial Distribution

  • 00841132134146 ()
01-1050-3000

  • Instrument tray, reusable
SM FRAG CASE LID
ORTHOPEDIATRICS CORP.
01-1050-2004
In Commercial Distribution

  • 00841132134108 ()
01-1050-2004

  • Instrument tray, reusable
SM FRAG CASE SHELL
ORTHOPEDIATRICS CORP.
01-1050-2001
In Commercial Distribution

  • 00841132134078 ()
01-1050-2001

  • Instrument tray, reusable
SMALL FRAG CASE COMPLETE
ORTHOPEDIATRICS CORP.
01-1050-2000
In Commercial Distribution

  • 00841132134061 ()
01-1050-2000

  • Instrument tray, reusable
PEDIPLATE LP CASE & TRAYS
ORTHOPEDIATRICS CORP.
01-1010-902
In Commercial Distribution

  • 00841132133927 ()
01-1010-902

  • Instrument tray, reusable
PEDIPLATE LP CASE, COMPLETE
ORTHOPEDIATRICS CORP.
01-1010-901
In Commercial Distribution

  • 00841132133910 ()
01-1010-901

  • Orthopaedic surgical procedure kit, non-medicated, reusable
PEDIPLATE II STERILIZATION CASE
ORTHOPEDIATRICS CORP.
01-1010-602
In Commercial Distribution

  • 00841132133859 ()
01-1010-602

  • Instrument tray, reusable
PEDIPLATE CASE SCREW CADDY
ORTHOPEDIATRICS CORP.
01-1010-016
In Commercial Distribution

  • 00841132133798 ()
01-1010-016

  • Instrument tray, reusable
PEDIFLEX STERILIZATION CASE - INSTRUMENTS
ORTHOPEDIATRICS CORP.
01-1000-301
In Commercial Distribution

  • 00841132133309 ()
01-1000-301

  • Instrument tray, reusable
CASE A02200558 REVISION MODULE
MEDICREA INTERNATIONAL
A02200558
In Commercial Distribution

  • 03613720293538 ()


  • Surgical instrument/implant rack
CASE A08240500 LIGAPASS - BASE
MEDICREA INTERNATIONAL
A08240500
In Commercial Distribution

  • 03613720286141 ()


  • Instrument tray, reusable
RICHARDS LAMBOTTE STERILIZING CASE
Smith & Nephew, Inc.
110425
In Commercial Distribution

  • 03596010494139 ()
110425

  • Instrument tray, reusable
JET-X CELTRAL INSTRUMENT CASE
Smith & Nephew, Inc.
71053050
In Commercial Distribution

  • 03596010486554 ()
71053050

  • Instrument tray, reusable
ALIF Disc Prep - Case
Restor3d, Inc.
5113-B0001
In Commercial Distribution

  • 00840097509952 ()


  • Instrument tray, reusable
CASE FOR IMPIX-MANTA TRIALS
MEDICREA INTERNATIONAL
A20120007
Not in Commercial Distribution

  • 03613720221425 ()


  • Surgical instrument/implant rack
CASE FOR IMPIX-MANTA INSTRUMENTS
MEDICREA INTERNATIONAL
A20120006
Not in Commercial Distribution

  • 03613720221418 ()


  • Surgical instrument/implant rack
CASE FOR TAP-LIF INSTRUMENTS
MEDICREA INTERNATIONAL
A15000100
Not in Commercial Distribution

  • 03613720215646 ()


  • Surgical instrument/implant rack
Graphic Instrument Case (3-High)
FLOWER ORTHOPEDICS CORPORATION
GCNGP
In Commercial Distribution

  • 00840118125192 ()


  • Device sterilization/disinfection container, reusable
Helix Instrument Graphic Case
FLOWER ORTHOPEDICS CORPORATION
OGC 001
In Commercial Distribution

  • 00840118124041 ()


  • Instrument tray, reusable
Graphic Instrument Case (3-High)
FLOWER ORTHOPEDICS CORPORATION
FTP 001
In Commercial Distribution

  • 00840118121545 ()


  • Device sterilization/disinfection container, reusable
Extraction Set Case Lid
VIANT MEDICAL
T14876
In Commercial Distribution

  • 00840096409994 ()
T14876

  • Instrument tray, reusable
TRIGEN META-NAIL INSTRUMENT CASE
Smith & Nephew, Inc.
71654550
In Commercial Distribution

  • 03596010585899 ()
71654550

  • Instrument tray, reusable
SHUTT ARTHROSCOPY INSTRUMENT CASE
Conmed Corporation
9899
In Commercial Distribution

  • 20845854026325 ()
  • 10845854026328 ()
9899

  • Instrument tray, reusable
LRC Tray Outer Case
Avalign Technologies, Inc.
940742
In Commercial Distribution

  • 00190776155605 ()


  • Instrument tray, reusable
Instrument Case Tray, Mini
Spine Wave, Inc.
13-3542
In Commercial Distribution

  • 10840642168563 ()
13-3542

  • Instrument tray, reusable
Instrument Case Base, Mini
Spine Wave, Inc.
13-3541
In Commercial Distribution

  • 10840642168556 ()
13-3541

  • Instrument tray, reusable
Transition Case - Tray 2
ORTHOPEDIATRICS CORP.
03-1600-1210
In Commercial Distribution

  • 00841132173343 ()
03-1600-1210

  • Instrument tray, reusable
Transition Case - Tray 1
ORTHOPEDIATRICS CORP.
03-1600-1110
In Commercial Distribution

  • 00841132173268 ()
03-1600-1110

  • Instrument tray, reusable
4.5/5.0 Case Base
ORTHOPEDIATRICS CORP.
03-1600-1001
In Commercial Distribution

  • 00841132173176 ()
03-1600-1001

  • Instrument tray, reusable
Cervical Instrument Case 6°
NEXXT SPINE, LLC
100N4101
In Commercial Distribution

  • 00840067203156 ()


  • Device sterilization/disinfection container, reusable
Cervical Instrument Case 0°
NEXXT SPINE, LLC
100N3101
In Commercial Distribution

  • 00840067203149 ()


  • Device sterilization/disinfection container, reusable
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