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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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Shukla Nail-BR S9NAIL-BR - B756SCS0480

Case, Broken Nail System
Shukla Medical
SCS048
In Commercial Distribution

  • B756SCS0480 ()


  • Instrument tray, reusable

Shukla Copter S9COPTER - B756SCS0440

Case, Helicopter Socket System
Shukla Medical
SCS044
In Commercial Distribution

  • B756SCS0440 ()


  • Instrument tray, reusable

Shukla Spine-TL S9SPINE-TL,Shukla Spine-CTL S9SPINE-CTL,Shukla Spine-C S9SPINE-C - B756SCS0360

Case, Spine System, Instruments
Shukla Medical
SCS036
In Commercial Distribution

  • B756SCS0360 ()


  • Instrument tray, reusable

Shukla Knee S9KNEE - B756SCA1010

Case & Tray, Knee System
Shukla Medical
SCA101
In Commercial Distribution

  • B756SCA1010 ()


  • Instrument tray, reusable

Guided Surgery Kit - D78562080

Guided Surgery Kit Case
OCO BIOMEDICAL INC
Guided Surgery Kit Case
In Commercial Distribution

  • D78562080 ()
6208

  • Surgical instrument/implant rack

Sinus Lift Surgical Kit - D78562060

Sinus Lift Surgical Case
OCO BIOMEDICAL INC
Sinus Lift Surgical Case
In Commercial Distribution

  • D78562060 ()
6206

  • Surgical instrument/implant rack

Engage Compact Kit - D78562050

Engage Compact Kit Case
OCO BIOMEDICAL INC
Engage Compact Kit Case
In Commercial Distribution

  • D78562050 ()
6205

  • Surgical instrument/implant rack

InCore Lapidus - 00817701021322

Instrument Case Lid Reusable
Medartis Inc.
IC-LAP-0123
In Commercial Distribution

  • 00817701021322 ()


  • Device sterilization/disinfection container, reusable

KineMatch® PFR System - 00818720013121

Autoclave Case, Nipple Mat
Kinamed, Inc.
22-800-1024
Not in Commercial Distribution

  • 00818720013121 ()
22-800-1024

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SuperCable® ISO-Elastic™ Cerclage System - 00818720012995

Cerclage Instruments Case Base
Kinamed, Inc.
35-800-1001
Not in Commercial Distribution

  • 00818720012995 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

SuperCable® ISO-Elastic™ Cerclage System - 00818720012988

Cerclage Instruments Case Lid
Kinamed, Inc.
35-800-1002
In Commercial Distribution

  • 00818720012988 ()
35-800-1002

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KineMatch® PFR System - 00818720010861

INSTRUMENT TRAY (AUTOCLAVE CASE)
Kinamed, Inc.
22-800-1020
In Commercial Distribution

  • 00818720010861 ()
22-800-1020

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Neodent - 07899878065500

ZI TRANSMUCOSAL MULTIKIT, CASE
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.345
In Commercial Distribution

  • 07899878065500 ()

  • Height: 67 Millimeter
  • Length: 195 Millimeter
  • Width: 90 Millimeter
110.345

  • Instrument tray, reusable

LiV™ Instruments - 00818354013139

LiV Instrument Sterilization Case
ATRICURE, INC.
001-300-700
In Commercial Distribution

  • 00818354013139 ()

  • Height: 4 Inch
  • Width: 10 Inch
  • Length: 20.5 Inch
N/A

  • Device sterilization/disinfection container, reusable

Neodent - 07899878061151

COMPLEMENT CASE (MODEL 2)
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.335
In Commercial Distribution

  • 07899878061151 ()
110.335

  • Instrument tray, reusable

Nuvo - 07899878061144

COMPLEMENT CASE (MODEL 2)
JJGC Indústria e Comércio de Materiais Dentários S/A.
CD1099002
In Commercial Distribution

  • 07899878061144 ()
CD1099002

  • Instrument tray, reusable

Neodent - 07899878059929

GM ZYGOMA-S SURGICAL CASE
JJGC Indústria e Comércio de Materiais Dentários S/A.
110321
In Commercial Distribution

  • 07899878059929 ()

  • Length: 264 Millimeter
  • Width: 163 Millimeter
110321

  • Instrument tray, reusable

Neodent - 07899878001584

COMPACT SURGICAL KIT CASE
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.268
In Commercial Distribution

  • 07899878001584 ()
110.268

  • Instrument tray, reusable

Neodent - 07899878001560

CM TRY-IN KIT CASE
JJGC Indústria e Comércio de Materiais Dentários S/A.
110.266
In Commercial Distribution

  • 07899878001560 ()
110.266

  • Instrument tray, reusable

Smart Correction - B562SCINS020

Instrument Case 2 Base
Wishbone Medical, Inc.
SC-INS-02
Not in Commercial Distribution

  • B562SCINS020 ()
SC-INS-02

  • Instrument tray, reusable

Smart Correction - B562SCTRAY02WB0

Instrument Case 2 Tray
Wishbone Medical, Inc.
SC-TRAY-02-WB
Not in Commercial Distribution

  • B562SCTRAY02WB0 ()
SC-TRAY-02-WB

  • Instrument tray, reusable

Smart Correction - B562SCTRAY01WB0

Instrument Case 1 Tray
Wishbone Medical, Inc.
SC-TRAY-01-WB
Not in Commercial Distribution

  • B562SCTRAY01WB0 ()
SC-TRAY-01-WB

  • Instrument tray, reusable

Smart Correction - B562SCSTRUTCASENSE0

Smart Correction Strut Case
Wishbone Medical, Inc.
SC-STRUTCASENS
Not in Commercial Distribution

  • B562SCSTRUTCASENSE0 ()


  • Instrument tray, reusable

Smart Correction - B562SCSTRUTCASE0

Smart Correction Strut Case
Wishbone Medical, Inc.
SC-STRUTCASE
Not in Commercial Distribution

  • B562SCSTRUTCASE0 ()
SC-STRUTCASE

  • Instrument tray, reusable

Smart Correction - B562SCRNG102WB0

Full Ring Case Tray
Wishbone Medical, Inc.
SC-RNG1-02-WB
Not in Commercial Distribution

  • B562SCRNG102WB0 ()
SC-RNG1-02-WB

  • Instrument tray, reusable

Smart Correction - B562SCRNG1010

Full Ring Case Base
Wishbone Medical, Inc.
SC-RNG1-01
Not in Commercial Distribution

  • B562SCRNG1010 ()
SC-RNG1-01

  • Instrument tray, reusable

Smart Correction - B562SCINS010

Instrument Case 1 Base
Wishbone Medical, Inc.
SC-INS-01
Not in Commercial Distribution

  • B562SCINS010 ()
SC-INS-01

  • Instrument tray, reusable

Morelli - 07895742264048

Sterilizable TAD toolkit case
Dental Morelli Ltda
37.20.002
In Commercial Distribution

  • 07895742264048 ()
37.20.002

  • Dental torque wrench

Sterile Spine Pedicle Screw System - B56209071000

B2B Outer Case Assembly
Wishbone Medical, Inc.
09.0710-0
Not in Commercial Distribution

  • B56209071000 ()
09.0710-0

  • Instrument tray, reusable

InterPlate® - 00817893022084

CASE/TRAY - 25mm TRAY
RSB SPINE LLC
L-Ti
In Commercial Distribution

  • 00817893022084 ()
RSB515

  • Instrument tray, reusable

InCore Subtalar - 00817701028765

InCore Subtalar Instrument Case
Medartis Inc.
ICSUBCASE
In Commercial Distribution

  • 00817701028765 ()


  • Device sterilization/disinfection container, reusable

InCore TMT - 00817701026938

InCore TMT Instrument Case
Medartis Inc.
IC-TMT-0122
In Commercial Distribution

  • 00817701026938 ()


  • Device sterilization/disinfection container, reusable

InCore MPJ - 00817701026174

InCore MPJ Instrument Case
Medartis Inc.
IC-MPJ-0122
In Commercial Distribution

  • 00817701026174 ()


  • Device sterilization/disinfection container, reusable

BIONIX RADIATION THERAPY - 00817740020065

B-SECUREFOAM, LAGE, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5038
Not in Commercial Distribution

  • 10817740020062 ()
  • 00817740020065 ()
BKRT-5038

  • Radiological whole-body positioner

BIONIX RADIATION THERAPY - 00817740020034

A-SECUREFOAM, SMALL, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5036
Not in Commercial Distribution

  • 10817740020031 ()
  • 00817740020034 ()
BKRT-5036

  • Radiological whole-body positioner

Tissue-Tek® Paraform® - 10615233081190

2-Lane Gels; 500/case
SAKURA FINETEK U.S.A., INC.
7046
In Commercial Distribution

  • 10615233081190 ()
  • 00615233081193 ()
7046

  • Histological tissue cassette biopsy insert IVD

Tissue-Tek® Paraform® - 10615233081183

Biopsy Gels; 500/case
SAKURA FINETEK U.S.A., INC.
7045
In Commercial Distribution

  • 10615233081183 ()
  • 00615233081186 ()
7045

  • Histological tissue cassette biopsy insert IVD

Sklar® - 10649111066245

NABATOFF STRIPPER KIT CASE
SKLAR CORPORATION
69-2021
In Commercial Distribution

  • 10649111066245 ()


  • Vein stripper, reusable

Arthrex® - 00888867364226

Primary Pilon Fusion Case
ARTHREX, INC.
AR-8963C-03
In Commercial Distribution

  • 00888867364226 ()
AR-8963C-03

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867354241

ALLOGRAFT OATS WORKSTATION CASE
ARTHREX, INC.
ABS-4081C
In Commercial Distribution

  • 00888867354241 ()
ABS-4081C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867354234

ALLOGRAFT OATS HARVESTER CASE
ARTHREX, INC.
ABS-4078C
In Commercial Distribution

  • 00888867354234 ()
ABS-4078C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867352759

Kreulock Comp.Screw Sysm Case
ARTHREX, INC.
AR-8787CLC
In Commercial Distribution

  • 00888867352759 ()
AR-8787CLC

  • Device sterilization/disinfection container, reusable

CORAIL - 10603295258636

CORAIL ALUMINUM BASE CASE
DEPUY (IRELAND)
L20500
In Commercial Distribution

  • 10603295258636 ()
L20500

  • Instrument tray, reusable

NA - 10603295255932

STERILIZATION CASE No.3
DEPUY (IRELAND)
CONTREE3
In Commercial Distribution

  • 10603295255932 ()
CONTREE3

  • Instrument tray, reusable

NA - 10603295255925

STERILIZATION CASE No.2
DEPUY (IRELAND)
CONTREE2
In Commercial Distribution

  • 10603295255925 ()
CONTREE2

  • Instrument tray, reusable

NA - 10603295255918

STERILIZATION CASE No.1
DEPUY (IRELAND)
CONTREE1
In Commercial Distribution

  • 10603295255918 ()
CONTREE1

  • Instrument tray, reusable

Arthrex® - 00888867400382

Shoulder Arthroscopy Instrument Case#
ARTHREX, INC.
AR-8405C
In Commercial Distribution

  • 00888867400382 ()
AR-8405C

  • Device sterilization/disinfection container, reusable

Arthrex® - 00888867390393

AUGMENTED VAULTLOCK INSTRUMENT CASE
ARTHREX, INC.
AR-9217AVC
In Commercial Distribution

  • 00888867390393 ()
AR-9217AVC

  • Device sterilization/disinfection container, reusable

NA - 10603295434351

Reach KNEE CASE 3
DEPUY (IRELAND)
9505-05-171
In Commercial Distribution

  • 10603295434351 ()
950505171

  • Instrument tray, reusable

PINNACLE - 10603295424277

PINNACLE BEARING REMOVAL CASE
DEPUY (IRELAND)
2220-00-200
In Commercial Distribution

  • 10603295424277 ()
222000200

  • Instrument tray, reusable
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