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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No Description
Biomet Orthopedics, LLC
1223
In Commercial Distribution

  • 00887868000218 ()
1223

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
110008481
In Commercial Distribution

  • 00887868109805 ()

  • 6.5MM / 8.0MM
110008481

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
110008471
In Commercial Distribution

  • 00887868109737 ()

  • 4.0MM / 5.0MM
110008471

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
110008469
In Commercial Distribution

  • 00887868109713 ()

  • 3.0MM
110008469

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
2810-02-016
In Commercial Distribution

  • 00887868027949 ()
281002016

  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
8299-40-000
In Commercial Distribution

  • 00887868050510 ()
829940000

  • Instrument tray, reusable
Orthopedic Tray
Epix Orthopaedics Inc.
5000-00001
In Commercial Distribution

  • B2215000000010 ()
5000-00001

  • Instrument tray, reusable
Tray
MIZUHO AMERICA, INC.
07-980-00
In Commercial Distribution

  • 00810009464303 ()


  • Instrument tray, reusable
Tray
MIZUHO AMERICA, INC.
07-944-44F
In Commercial Distribution

  • 00810009464020 ()


  • Instrument tray, reusable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Pelican Case
In Commercial Distribution

  • 27290114061364 ()
700-000888-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Pelican Case
In Commercial Distribution

  • 27290114063702 ()
700-000888-00

  • Neurological stereotactic surgery system
Twin Transport Case for the Novoste Beta-Cath System
BEST VASCULAR, INC.
TRC-0002
In Commercial Distribution

  • M097TRC00020 ()
TRC-0002

  • Manual-afterloading brachytherapy system source transfer device transport case/set
Guided Case Planning
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118145998 ()
TGC-0001

  • Dental implant system
A distraction-compression case is a kit, or a set of instruments designed to perform distraction and compression on a bony structure. The instruments within the case are used to: Distract: To pull apart or lengthen two adjacent bony segments. This is often done to restore anatomical alignment, decompress a nerve, or create a space for a bone graft or implant. Compress: To push together two bony segments. This is typically done to stabilize a fracture, achieve a solid fusion, or close a gap between bones. These kits are essential for orthopedic and spinal surgeons to manipulate bones and achieve proper fixation
Bradshaw Medical, Inc.
MRS-103
In Commercial Distribution

  • 00810019931475 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
No Description
Advanced Bionics, LLC
305-Q274-004
In Commercial Distribution

  • 00840094415669 ()


  • Cochlear implant/auditory brainstem implant sound processor
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9932
In Commercial Distribution

  • 00848665024319 ()


  • Instrument tray, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9931
In Commercial Distribution

  • 00848665024302 ()


  • Instrument tray, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9930
In Commercial Distribution

  • 00848665024296 ()


  • Instrument tray, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9929
In Commercial Distribution

  • 00848665024289 ()


  • Instrument tray, reusable
PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution

  • 00850012625148 ()
0204-2100-079#P10

  • Implantable cardiac device management application software
EXD Carrying Case
Avertix Medical Inc.
0203-2100-004
In Commercial Distribution

  • 00850012625049 ()
0203-2100-004

  • Implantable cardiac monitor programmer/transmitter/alarm
Sterilisation Case - Implants
AXIS SPINE TECHNOLOGIES LTD
2984 00 100
In Commercial Distribution

  • 05056619800314 ()
2984 00 100

  • Device sterilization/disinfection container, reusable
Sterilisation Case - Lid
AXIS SPINE TECHNOLOGIES LTD
2984 00 000
In Commercial Distribution

  • 05056619800307 ()
2984 00 000

  • Device sterilization/disinfection container, reusable
PUMP CASE PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0714777AG
In Commercial Distribution

  • 10889942085279 ()
DYNJ0714777AG

  • General surgical procedure kit, non-medicated, reusable
Pivot Sterilization Case
RP Medical Inc
39-1960-100
In Commercial Distribution

  • 00850032955003 ()


  • Instrument tray, reusable
Aesculap Instrument Case
Fusion Robotics, LLC
1102
In Commercial Distribution

  • 00850026574715 ()


  • Robotic surgical navigation system
Composite Carrying Case
Enova Illumination, Inc.
5460-700-029
In Commercial Distribution

  • 00850025993098 ()
5460-700-029

  • Head-worn lamp
PUMP CASE PACK
MEDLINE INDUSTRIES, INC.
DYNJ63701B
In Commercial Distribution

  • 40193489415132 ()
  • 10193489415131 ()
DYNJ63701B

  • General surgical procedure kit, non-medicated, single-use
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUSE
In Commercial Distribution

  • 50888439900215 ()
  • 10888439900217 ()
SBA41PCUSE

  • General surgical procedure kit, medicated
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUS4
In Commercial Distribution

  • 50888439887363 ()
  • 10888439887365 ()
SBA41PCUS4

  • General surgical procedure kit, medicated
Tray; 32/case
SAKURA FINETEK U.S.A., INC.
3981
In Commercial Distribution

  • 00615233013279 ()
3981

  • Microscope slide tray
Airrapy Pillow Case
CARILEX MEDICAL, INC.
S2509-A010
In Commercial Distribution

  • 04713616092814 ()
  • 04713616093491 ()


  • Alternating-pressure bed mattress overlay system
Instrument Case 1
Xtant Medical Holdings, Inc.
02-CASE-DEF-EMPTY1
Not in Commercial Distribution

  • 00846468099985 ()
02-CASE-DEF-EMPTY1

  • Device sterilization/disinfection container, reusable
Instrument Case 2
Xtant Medical Holdings, Inc.
02-CASE-DEF-EMPTY2
Not in Commercial Distribution

  • 00846468099978 ()
02-CASE-DEF-EMPTY2

  • Device sterilization/disinfection container, reusable
Rasping Trial Case
Pioneer Surgical Technology, Inc.
64-UNISON-C-RT-E
Not in Commercial Distribution

  • 00846468083816 ()
64-UNISON-C-RT-E

  • Device sterilization/disinfection container, reusable
Instrument Case, Empty
Xtant Medical Holdings, Inc.
02-DEFORM-CASE2-E
Not in Commercial Distribution

  • 00846468080839 ()
02-DEFORM-CASE2-E

  • Device sterilization/disinfection container, reusable
Instrument Case, Empty
Xtant Medical Holdings, Inc.
02-DEFORM-CASE1-E
Not in Commercial Distribution

  • 00846468080822 ()
02-DEFORM-CASE1-E

  • Device sterilization/disinfection container, reusable
Instrument Case, Empty
Xtant Medical Holdings, Inc.
02-EXP-INS-CASE-E
Not in Commercial Distribution

  • 00846468080815 ()
02-EXP-INS-CASE-E

  • Device sterilization/disinfection container, reusable
Instrument Case, Empty
Xtant Medical Holdings, Inc.
02-STRM-INS-CASE-E
Not in Commercial Distribution

  • 00846468080808 ()
02-STRM-INS-CASE-E

  • Device sterilization/disinfection container, reusable
Case, Crosslink, Empty
Xtant Medical Holdings, Inc.
02-XLNK-CASE-E
Not in Commercial Distribution

  • 00846468080785 ()
02-XLNK-CASE-E

  • Device sterilization/disinfection container, reusable
Implant Case, Empty
Xtant Medical Holdings, Inc.
02-EXP-IMP-CASE-E
Not in Commercial Distribution

  • 00846468080723 ()
02-EXP-IMP-CASE-E

  • Device sterilization/disinfection container, reusable
Implant Case, Empty
Xtant Medical Holdings, Inc.
02-STRM-IMP-CASE-E
Not in Commercial Distribution

  • 00846468080518 ()
02-STRM-IMP-CASE-E

  • Device sterilization/disinfection container, reusable
INSTRUMENT CASE, THORACOLUMBAR
Pioneer Surgical Technology, Inc.
10-INSTCASE-TL
Not in Commercial Distribution

  • 00846468002169 ()
10-INSTCASE-TL

  • General internal orthopaedic fixation system implantation kit
IMPLANT CASE, THORACOLUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE-TL
Not in Commercial Distribution

10-IMPCASE-TL

  • General internal orthopaedic fixation system implantation kit
CASE, ROD CUTTER
Xtant Medical Holdings, Inc.
10-CUTTERCASE
Not in Commercial Distribution

10-CUTTERCASE

  • Device sterilization/disinfection container, reusable
Angled Inserter Case
Pioneer Surgical Technology, Inc.
65-L-INSERT-CASE-A
Not in Commercial Distribution

  • 00846468000370 ()
65-L-INSERT-CASE-A

  • Device sterilization/disinfection container, reusable
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUS3
In Commercial Distribution

  • 50888439543085 ()
  • 10888439543087 ()
SBA41PCUS3

  • General surgical procedure kit, medicated
CASE 2000028 LID
MEDTRONIC SOFAMOR DANEK, INC.
2000028
In Commercial Distribution

  • 00613994990860 ()


  • Instrument tray, reusable
CASE 2000024 BASE
MEDTRONIC SOFAMOR DANEK, INC.
2000024
In Commercial Distribution

  • 00613994990822 ()


  • Instrument tray, reusable
Single Compartment Case
OSTEOMED LLC
220-0622
In Commercial Distribution

  • 00845694034616 ()
220-0622

  • General internal orthopaedic fixation system implantation kit
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