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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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Universal SteriBump® - 00696588002088

Universal SteriBump® Sterile (5/case)
Innovative Medical Products, Inc
508
Not in Commercial Distribution

  • 00696588002088 ()
  • 00696588001319 ()
508

  • Freestanding patient positioner, single-use

Universal Distractor Pad - 00696588000909

Universal Distractor Pad - Non-sterile 10/case
Innovative Medical Products, Inc
907-NSP
In Commercial Distribution

  • 00696588000909 ()
907-NSP

  • Surgical linen/cushion set

GrindRelief PRO - 00866618000050

Thermoplastic mouth guard - Case of 3
Grind Guard Technologies, L.L.C.
203
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000050 ()
203

  • Mouthguard, reusable

GrindRelief PRO - 00866618000043

Thermoplastic mouth guard - Case of 12
Grind Guard Technologies, L.L.C.
212
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000043 ()
212

  • Mouthguard, reusable

GrindRelief PRO - 00866618000036

Thermoplastic mouth guard - Case of 10
Grind Guard Technologies, L.L.C.
210
In Commercial Distribution

  • 10866618000033 ()
  • 00866618000036 ()
210

  • Mouthguard, reusable

Stainless Steel - 10889981027506

Uniplanar Screws 6.35mm Sterilization Case Assembly
Seaspine Orthopedics Corporation
SSDF4DPIMP
In Commercial Distribution

  • 10889981027506 ()
SSDF4DPIMP

  • Bone-screw internal spinal fixation system, non-sterile

Stainless Steel - 10889981027490

Polyaxial Screws 6.35mm Sterilization Case Assembly
Seaspine Orthopedics Corporation
SSDF3PSIMP
In Commercial Distribution

  • 10889981027490 ()
SSDF3PSIMP

  • Bone-screw internal spinal fixation system, non-sterile

First Aid Only - 00738743007078

CPR LAERDAL POCKET MASK SOFT Case
Acme United Corporation
363015
In Commercial Distribution

  • 00738743007078 ()
363015

  • Cardiopulmonary resuscitation mask, single-use

CARDINAL HEALTH - 10195594467043

PERMANENT IT CASE PACKS W CHLO
Cardinal Health 200, LLC
SBA42PIMS1
In Commercial Distribution

  • 50195594467041 ()
  • 10195594467043 ()
SBA42PIMS1

  • General surgical procedure kit, medicated

N/A - 00613994302113

CASE 7038510INT OUTER LEGACY MINI SS
MEDTRONIC SOFAMOR DANEK, INC.
7038510INT
Not in Commercial Distribution

  • 00613994302113 ()


  • Instrument tray, reusable

N/A - 00613994302038

CASE 7039510INT OUTER LEGACY MINI TI
MEDTRONIC SOFAMOR DANEK, INC.
7039510INT
In Commercial Distribution

  • 00613994302038 ()


  • Instrument tray, reusable

N/A - 00613994300614

CASE 7220011 PERC PEEK ROD TRAY
MEDTRONIC SOFAMOR DANEK, INC.
7220011
In Commercial Distribution

  • 00613994300614 ()


  • Instrument tray, reusable

N/A - 00613994259035

CASE 7573001 SEXTANT II REDUCTION OUTER
MEDTRONIC SOFAMOR DANEK, INC.
7573001
In Commercial Distribution

  • 00613994259035 ()


  • Instrument tray, reusable

Prestige(R) Cervical Disc System - 00613994257321

CASE 6971420 PRESTIGE ST INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
6971420
In Commercial Distribution

  • 00613994257321 ()


  • Instrument tray, reusable

N/A - 00613994257284

CASE 7080928 ATL TX CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
7080928
In Commercial Distribution

  • 00613994257284 ()


  • Instrument tray, reusable

Clydesdale™ Spinal System - 00613994248411

CASE 2940100 2 DISTRACTOR INSRTR RMVL
MEDTRONIC SOFAMOR DANEK, INC.
2940100
In Commercial Distribution

  • 00613994248411 ()


  • Instrument tray, reusable

DIAM™ Spinal Stabilization System - 00613994243928

CASE 9491224 DIAM INSERTER INSTRUMENT TR
MEDTRONIC SOFAMOR DANEK, INC.
9491224
In Commercial Distribution

  • 00613994243928 ()


  • Instrument tray, reusable

N/A - 00613994234728

CASE X0804400 CUSTOM THREADED MODULR ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0804400
In Commercial Distribution

  • 00613994234728 ()


  • Instrument tray, reusable

N/A - 00613994232045

CASE 1858711 CDHL ANTERIOR SCREW GAUGE
MEDTRONIC SOFAMOR DANEK, INC.
1858711
In Commercial Distribution

  • 00613994232045 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00613994231925

CASE 1858700L CDHL ANTERIOR OUTER LID
MEDTRONIC SOFAMOR DANEK, INC.
1858700L
In Commercial Distribution

  • 00613994231925 ()


  • Instrument tray, reusable

N/A - 00613994231826

CASE 1858710 CDHL ANT CROSSLINK MODULE
MEDTRONIC SOFAMOR DANEK, INC.
1858710
In Commercial Distribution

  • 00613994231826 ()


  • Instrument tray, reusable

N/A - 00613994225030

CASE 7059500 CORTICAL BONE SCREW OUTER
MEDTRONIC SOFAMOR DANEK, INC.
7059500
In Commercial Distribution

  • 00613994225030 ()


  • Instrument tray, reusable

N/A - 00613994213891

CASE 9590000 CRESCENT 30MM LENGTH TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
9590000
In Commercial Distribution

  • 00613994213891 ()


  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994566140

CASE 7757044L OC ROD CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
7757044L
In Commercial Distribution

  • 00613994566140 ()


  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994566126

CASE 7757042L OC SCREW CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
7757042L
In Commercial Distribution

  • 00613994566126 ()


  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994566102

CASE 7757040L SCREW CONNECTOR CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
7757040L
In Commercial Distribution

  • 00613994566102 ()


  • Instrument tray, reusable

N/A - 00613994560551

CASE 1859025 LEGACY 5.5 NAV DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
1859025
Not in Commercial Distribution

  • 00613994560551 ()


  • Instrument tray, reusable

N/A - 00613994190406

CASE 635500 VERTESTCK PERIMETER OUTR CAS
MEDTRONIC SOFAMOR DANEK, INC.
635500
In Commercial Distribution

  • 00613994190406 ()


  • Instrument tray, reusable

N/A - 00613994190017

CASE 3299012 PERIMETER XL TRIAL CADDY
MEDTRONIC SOFAMOR DANEK, INC.
3299012
In Commercial Distribution

  • 00613994190017 ()


  • Instrument tray, reusable

N/A - 00613994185129

CASE 9182054 TEMPLTS AND INSERTRS TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9182054
In Commercial Distribution

  • 00613994185129 ()


  • Instrument tray, reusable

N/A - 00613994185112

CASE 9182053 RESECTION GUID DISTR TEMPLT
MEDTRONIC SOFAMOR DANEK, INC.
9182053
In Commercial Distribution

  • 00613994185112 ()


  • Instrument tray, reusable

N/A - 00613994185099

CASE 9182051 ENDPLATE PREP RONGEUR TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9182051
In Commercial Distribution

  • 00613994185099 ()


  • Instrument tray, reusable

N/A - 00613994185082

CASE 9182050 ENDPLTE PREP ROUGEUR OUTER
MEDTRONIC SOFAMOR DANEK, INC.
9182050
In Commercial Distribution

  • 00613994185082 ()


  • Instrument tray, reusable

N/A - 00613994177162

CASE 8359108 TSRH TC SCREW MODULE
MEDTRONIC SOFAMOR DANEK, INC.
8359108
In Commercial Distribution

  • 00613994177162 ()


  • Instrument tray, reusable

N/A - 00613994177094

CASE X0406070 SPEC CROSSLINK INST TRAY
MEDTRONIC SOFAMOR DANEK, INC.
X0406070
Not in Commercial Distribution

  • 00613994177094 ()


  • Instrument tray, reusable

N/A - 00613994165978

CASE 7056135L 6.35APICAL DRTATR OUTR LID
MEDTRONIC SOFAMOR DANEK, INC.
7056135L
In Commercial Distribution

  • 00613994165978 ()


  • Instrument tray, reusable

N/A - 00613994161574

CASE 8690001 COBALT CHROME ROD MODULE
MEDTRONIC SOFAMOR DANEK, INC.
8690001
In Commercial Distribution

  • 00613994161574 ()


  • Instrument tray, reusable

TSRH® Spinal System - 00613994154774

CASE 8350276 TSRH TC SCREW GAUGE
MEDTRONIC SOFAMOR DANEK, INC.
8350276
In Commercial Distribution

  • 00613994154774 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00613994152930

CASE 7049483 4.5 HOOK MODULE SS
MEDTRONIC SOFAMOR DANEK, INC.
7049483
In Commercial Distribution

  • 00613994152930 ()


  • Instrument tray, reusable

N/A - 00613994152909

CASE 7049473 4.5 HOOK MODULE TI
MEDTRONIC SOFAMOR DANEK, INC.
7049473
In Commercial Distribution

  • 00613994152909 ()


  • Instrument tray, reusable
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