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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Angled Instruments Case (Empty)
PRECISION SPINE, INC.
60-SC-4000
In Commercial Distribution

  • 00840019918855 ()
60-SC-4000

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Implantation Instruments Case (Empty)
PRECISION SPINE, INC.
60-SC-2000
In Commercial Distribution

  • 00840019918831 ()
60-SC-2000

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Cobbs / Curettes Case (Empty)
PRECISION SPINE, INC.
60-SC-1000
In Commercial Distribution

  • 00840019918824 ()
60-SC-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Adjunct Rasp Sterilization Case
PRECISION SPINE, INC.
37-SC-0202
In Commercial Distribution

  • 00840019917247 ()
37-SC-0202

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Anterolateral Disc Prep, Case
NEXXT SPINE, LLC
C62-01-02
In Commercial Distribution

  • 00889929038772 ()


  • Device sterilization/disinfection container, reusable
Inertia Rod Manipulation Case
NEXXT SPINE, LLC
C10-01-16
In Commercial Distribution

  • 00889929018569 ()


  • Device sterilization/disinfection container, reusable
Inertia Rod Manipulation Case
NEXXT SPINE, LLC
C10-01-02
In Commercial Distribution

  • 00889929018477 ()


  • Device sterilization/disinfection container, reusable
Inertia Screw Insertion Case
NEXXT SPINE, LLC
C10-01-01
In Commercial Distribution

  • 00889929018460 ()


  • Device sterilization/disinfection container, reusable
Honour Cervical Interbody Case
NEXXT SPINE, LLC
C35-01-01
In Commercial Distribution

  • 00889929017227 ()


  • Device sterilization/disinfection container, reusable
Honour Disc Preparation Case
NEXXT SPINE, LLC
C21-02-02
In Commercial Distribution

  • 00889929017180 ()


  • Device sterilization/disinfection container, reusable
Stand Alone Cervical Case
NEXXT SPINE, LLC
C52N-01-01
In Commercial Distribution

  • 00889929045794 ()


  • Device sterilization/disinfection container, reusable
Case, Spine System, Instruments
Shukla Medical
CA184
In Commercial Distribution

  • B756CA1840 ()


  • Instrument tray, reusable
Case, Modular Hip System
Shukla Medical
120-01
In Commercial Distribution

  • B756120010 ()


  • Instrument tray, reusable
Case & Lid, MAXI System
Shukla Medical
SCS240
In Commercial Distribution

  • B756SCS2400 ()


  • Instrument tray, reusable
Shoulder System, Case 2
Shukla Medical
SCS068
In Commercial Distribution

  • B756SCS0680 ()


  • Instrument tray, reusable
Shoulder System Case 1
Shukla Medical
SCS067
In Commercial Distribution

  • B756SCS0670 ()


  • Instrument tray, reusable
Shoulder Blade System Case
Shukla Medical
SCS062
In Commercial Distribution

  • B756SCS0620 ()


  • Instrument tray, reusable
Case, Lag Screw System
Shukla Medical
SCS051
In Commercial Distribution

  • B756SCS0510 ()


  • Instrument tray, reusable
Case, Broken Nail System
Shukla Medical
SCS048
In Commercial Distribution

  • B756SCS0480 ()


  • Instrument tray, reusable
Case, Helicopter Socket System
Shukla Medical
SCS044
In Commercial Distribution

  • B756SCS0440 ()


  • Instrument tray, reusable
Case, Spine System, Instruments
Shukla Medical
SCS036
In Commercial Distribution

  • B756SCS0360 ()


  • Instrument tray, reusable
Case & Tray, Knee System
Shukla Medical
SCA101
In Commercial Distribution

  • B756SCA1010 ()


  • Instrument tray, reusable
Case for Tenolysis Instruments
Buxton Biomedical Inc
54-5191
In Commercial Distribution

  • B7685451910 ()
54-5191

  • Device sterilization/disinfection container, reusable
Offset Femur Provisional Case
TOTAL JOINT ORTHOPEDICS, INC.
1408.00.000
In Commercial Distribution

  • 00819251021951 ()


  • Instrument tray, reusable
Specimen Trap - 10/case
DORNOCH MEDICAL SYSTEMS, INC.
UL-ST100
In Commercial Distribution

  • 70889024578684 ()
  • 00889024578685 ()
UL-ST100

  • Surgical fluid/smoke waste management system suction unit
Stable-L Sterile Implant Case
NEXUS SPINE, L.L.C.
825117
Not in Commercial Distribution

  • B6788251170 ()


  • Metallic spinal interbody fusion cage
Spinal Jaxx Instrument Case
NEUROPRO SPINAL JAXX INC.
100001-390
In Commercial Distribution

  • 00818956020566 ()
100001-390

  • Surgical instrument/implant rack
Autoclave Case, Nipple Mat
Kinamed, Inc.
22-800-1024
Not in Commercial Distribution

  • 00818720013121 ()
22-800-1024

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Cerclage Instruments Case Base
Kinamed, Inc.
35-800-1001
Not in Commercial Distribution

  • 00818720012995 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Cerclage Instruments Case Lid
Kinamed, Inc.
35-800-1002
In Commercial Distribution

  • 00818720012988 ()
35-800-1002

  • Orthopaedic surgical procedure kit, non-medicated, reusable
INSTRUMENT TRAY (AUTOCLAVE CASE)
Kinamed, Inc.
22-800-1020
In Commercial Distribution

  • 00818720010861 ()
22-800-1020

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Lateral SI Case/Lid
Spinal Simplicity, LLC
30-0023-000
In Commercial Distribution

  • M9433000230000 ()


  • Instrument tray, reusable
Posterior MIS Case/Tray
Spinal Simplicity, LLC
30-0003-000
In Commercial Distribution

  • M9433000030000 ()


  • Instrument tray, reusable
Instrument Case Lid Reusable
Medartis Inc.
IC-LAP-0123
In Commercial Distribution

  • 00817701021322 ()


  • Device sterilization/disinfection container, reusable
Electrodes (600 per case)
VASOMEDICAL, INC.
Model Lumenair
In Commercial Distribution

  • 00817980020917 ()
V93-0020

  • Electrocardiographic electrode, single-use
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
FH Disc Prep Case
Integrity Implants Inc.
II-1-0354
In Commercial Distribution

  • 00818613020106 ()
II-1-0354

  • Instrument tray, reusable
CASE/TRAY - 25mm TRAY
RSB SPINE LLC
L-Ti
In Commercial Distribution

  • 00817893022084 ()
RSB515

  • Instrument tray, reusable
InCore Subtalar Instrument Case
Medartis Inc.
ICSUBCASE
In Commercial Distribution

  • 00817701028765 ()


  • Device sterilization/disinfection container, reusable
InCore TMT Instrument Case
Medartis Inc.
IC-TMT-0122
In Commercial Distribution

  • 00817701026938 ()


  • Device sterilization/disinfection container, reusable
InCore MPJ Instrument Case
Medartis Inc.
IC-MPJ-0122
In Commercial Distribution

  • 00817701026174 ()


  • Device sterilization/disinfection container, reusable
B-SECUREFOAM, LAGE, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5038
Not in Commercial Distribution

  • 10817740020062 ()
  • 00817740020065 ()
BKRT-5038

  • Radiological whole-body positioner
A-SECUREFOAM, SMALL, BULK CASE
Bionix Radiation Therapy, LLC
BKRT-5036
Not in Commercial Distribution

  • 10817740020031 ()
  • 00817740020034 ()
BKRT-5036

  • Radiological whole-body positioner
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
DENPLANT SMALL LOWER CASE
CMP INDUSTRIES LLC
689226-12
In Commercial Distribution

  • M482689226120 ()


  • Bite registration rim
DENPLANT SMALL UPPER CASE
CMP INDUSTRIES LLC
687629-12
In Commercial Distribution

  • M482687629120 ()


  • Bite registration rim
DENPLANT LARGE UPPER CASE
CMP INDUSTRIES LLC
687432-12
In Commercial Distribution

  • M482687432120 ()


  • Bite registration rim
DENPLANT LARGE LOWER CASE
CMP INDUSTRIES LLC
687328-12
In Commercial Distribution

  • M482687328120 ()


  • Bite registration rim
Case with 256 cartridges.
BACTERIOSCAN, INC.
Clear Cartridge - 4 Well Case
In Commercial Distribution

  • B90900522 ()
  • B9090052 ()


  • Microbial incubator/imaging system IVD
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