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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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Arthrex® - 00888867010796

OSTEOTOMY PLATE CASE
ARTHREX, INC.
AR-13307P
In Commercial Distribution

  • 00888867010796 ()
AR-13307P

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867006812

PCL TOOLBOX CASE
ARTHREX, INC.
AR-1269C
In Commercial Distribution

  • 00888867006812 ()
AR-1269C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867021532

UNIVERSAL INSTRUMENTATION CASE
ARTHREX, INC.
AR-1817C
In Commercial Distribution

  • 00888867021532 ()
AR-1817C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867043664

SHOULDER INSTRUMENT CASE
ARTHREX, INC.
AR-8402C
In Commercial Distribution

  • 00888867043664 ()
AR-8402C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867035782

GRAFTBOLT INSTRUMENT CASE
ARTHREX, INC.
AR-5100C
In Commercial Distribution

  • 00888867035782 ()
AR-5100C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867032989

TRIM-IT INSTRUMENTATION CASE
ARTHREX, INC.
AR-4160C
In Commercial Distribution

  • 00888867032989 ()
AR-4160C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867029095

VIDEO INSTRUMENT CASE
ARTHREX, INC.
AR-3101C
In Commercial Distribution

  • 00888867029095 ()
AR-3101C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867026148

WISHBONE INSTRUMENT CASE
ARTHREX, INC.
AR-2180W
In Commercial Distribution

  • 00888867026148 ()
AR-2180W

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867026131

MASTER INSTRUMENT CASE
ARTHREX, INC.
AR-2180M
In Commercial Distribution

  • 00888867026131 ()
AR-2180M

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867025585

STERILIZATION CASE, OATS
ARTHREX, INC.
AR-1992
In Commercial Distribution

  • 00888867025585 ()
AR-1992

  • Device sterilization/disinfection container, reusable

Parcus Instrumentation - 00816342022019

ACL Tray Case
PARCUS MEDICAL LLC
20018
In Commercial Distribution

  • 00816342022019 ()


  • Surgical instrument/implant rack

Arthrex® - 00888867044883

PLAPLE INSTRUMENT CASE
ARTHREX, INC.
AR-8714C
In Commercial Distribution

  • 00888867044883 ()
AR-8714C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867046634

ENDOSCOPIC GRS CASE
ARTHREX, INC.
AR-8808
In Commercial Distribution

  • 00888867046634 ()
AR-8808

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867044395

ANKLE ARTHROSCOPY CASE
ARTHREX, INC.
AR-8655C
In Commercial Distribution

  • 00888867044395 ()
AR-8655C

  • Device sterilization/disinfection container, reusable

Integra® Jarit® - 10381780177050

DIETHRICH BYPASS CASE
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
310-381
Not in Commercial Distribution

  • M2743103811 ()
  • 10381780177050 ()


  • Device sterilization/disinfection container, reusable

Integra® Miltex® - 10381780177012

Micro Instrument Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-576
Not in Commercial Distribution

  • H83435761 ()
  • 10381780177012 ()
3-576

  • Instrument tray, reusable

Integra® Miltex® - 10381780169901

Micro Instrument Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-574
Not in Commercial Distribution

  • H83435741 ()
  • 10381780169901 ()
3-574

  • Instrument tray, reusable

Integra® Miltex® - 10381780169895

Micro Instrument Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-572
Not in Commercial Distribution

  • H83435721 ()
  • 10381780169895 ()
3-572

  • Instrument tray, reusable

Integra® Miltex® - 10381780169864

Micro Instrument Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-554
Not in Commercial Distribution

  • H83435541 ()
  • 10381780169864 ()
3-554

  • Instrument tray, reusable

Integra® Miltex® - 10381780169840

Micro Instrument Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-552
Not in Commercial Distribution

  • H83435521 ()
  • 10381780169840 ()
3-552

  • Instrument tray, reusable

Integra® Miltex® - 10381780169826

Micro Instrument Case
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
3-550
Not in Commercial Distribution

  • H83435501 ()
  • 10381780169826 ()
3-550

  • Instrument tray, reusable

CRW® - 10381780355731

CASE PS2 MODIFIED
INTEGRA LIFESCIENCES CORPORATION
S72901984
Not in Commercial Distribution

  • M248S729019841 ()
  • 10381780355731 ()


  • Stereotactic radiosurgical invasive head frame

Integra® Spider™ Limted Wrist Fusion System - 10381780280798

STERILIZATION CASE LID
Ascension Orthopedics, Inc.
075022
Not in Commercial Distribution

  • M2480750221 ()
  • 10381780280798 ()

  • 1.01" Height
075022

  • Instrument tray, reusable

KGTI™ Kinetik Great Toe Implant System - 10381780279761

KGTI STERILIZATION CASE
Ascension Orthopedics, Inc.
015001
Not in Commercial Distribution

  • M2480150011 ()
  • 10381780279761 ()
015001

  • Device sterilization/disinfection container, reusable

Surgical Direct - B382SD482140

TL Sterilization CASE
Surgical Direct, Inc.
SD48214
In Commercial Distribution

  • B382SD482140 ()
SD48214

  • Self-retaining surgical retractor, reusable

Integra® Jarit® - 10381780145783

TRUMPET VALVE CASE
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
6003005
Not in Commercial Distribution

  • M27460030051 ()
  • 10381780145783 ()
600-3005

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

BUDDE® - 10381780255833

Halo Case Lid
INTEGRA LIFESCIENCES CORPORATION
438A1189
In Commercial Distribution

  • M268438A11891 ()
  • 10381780255833 ()


  • Neurosurgical retraction system, brain

Cortium Universal OCT Spinal Fixation System - 00814386029049

Outer case lid
Ulrich Medical Usa, Inc.
UU000-00-01
In Commercial Distribution

  • 00814386029049 ()


  • Instrument tray, reusable

APTUS - 07630894804915

Case CMC-I Fusion
Medartis AG
A-6604.901
In Commercial Distribution

A-6604.901

  • Device sterilization/disinfection container, reusable

APTUS - 07630894803307

Sterilizing Case, 260x270x120mm
Medartis AG
A-6040
In Commercial Distribution

A-6040

  • Device sterilization/disinfection container, reusable
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