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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AA INSTRUMENT CASE OUTER
SYMMETRY MEDICAL INC.
25-051-003
In Commercial Distribution

  • 00847538010985 ()
259807020

  • Device sterilization/disinfection container, reusable
Bow Tie Reamer Case
TORNIER, INC.
9028049
In Commercial Distribution

  • 00846832099252 ()
9028049

  • Bone-resection orthopaedic reamer, reusable
Fracture Reamers Case Base
TORNIER, INC.
NBR10461
In Commercial Distribution

  • 00846832093663 ()
NBR10461

  • Instrument tray, reusable
Fracture JIG Case Base
TORNIER, INC.
NBR10441
In Commercial Distribution

  • 00846832093601 ()
NBR10441

  • Instrument tray, reusable
Fracture Instruments Case Base
TORNIER, INC.
NBR10411
In Commercial Distribution

  • 00846832093571 ()
NBR10411

  • Instrument tray, reusable
Antibody Diluent, 4/case
SAKURA FINETEK U.S.A., INC.
8867-G004
In Commercial Distribution

  • 00615233002488 ()
8867-G004

  • Immunohistochemistry antibody diluent IVD
ALIF Standard Trial Case
Pioneer Surgical Technology, Inc.
65-A-TRIAL-CASE
In Commercial Distribution

  • 00846468099107 ()
65-A-TRIAL-CASE

  • Device sterilization/disinfection container, reusable
ALIF 20° Trial Case
Pioneer Surgical Technology, Inc.
65-A-TRIAL-20-CASE
In Commercial Distribution

  • 00846468099084 ()
65-A-TRIAL-20-CASE

  • Device sterilization/disinfection container, reusable
Pre-Bent Rod Case, Empty
Xtant Medical Holdings, Inc.
26-PBROD-SET-E
Not in Commercial Distribution

  • 00846468095635 ()
26-PBROD-SET-E

  • Device sterilization/disinfection container, reusable
ALIF 30° Trial Case
Pioneer Surgical Technology, Inc.
65-A-TRIAL-30-CASE
In Commercial Distribution

  • 00846468099091 ()
65-A-TRIAL-30-CASE

  • Device sterilization/disinfection container, reusable
UTF Stem Case #3
UNITED ORTHOPEDIC CORP.
9106-8030
In Commercial Distribution

  • 04719872172727 ()
9106-8030

  • Instrument tray, reusable
UTF Stem case #2
UNITED ORTHOPEDIC CORP.
9106-8020
In Commercial Distribution

  • 04719872172703 ()
9106-8020

  • Instrument tray, reusable
U2 Hip basic case
UNITED ORTHOPEDIC CORP.
9104-8110
In Commercial Distribution

  • 04719872172406 ()
9104-8110

  • Instrument tray, reusable
Flexible reamer set case
UNITED ORTHOPEDIC CORP.
9104-8060
In Commercial Distribution

  • 04719872172390 ()
9104-8060

  • Instrument tray, reusable
Case U2 Stem B
UNITED ORTHOPEDIC CORP.
9104-8030
In Commercial Distribution

  • 04719872172369 ()
9104-8030

  • Instrument tray, reusable
Case U2 Stem A
UNITED ORTHOPEDIC CORP.
9104-8010-RA
In Commercial Distribution

  • 04719872172345 ()
9104-8010-RA

  • Instrument tray, reusable
UPPER EXTREMITY HAND CASE
MEDLINE INDUSTRIES, INC.
DYNJ40597B
In Commercial Distribution

  • 40193489294010 ()
  • 10193489294019 ()
DYNJ40597B

  • General surgical procedure kit, non-medicated, single-use
UTF Stem case #1
UNITED ORTHOPEDIC CORP.
9106-8010
In Commercial Distribution

  • 04719872179139 ()
9106-8010

  • Instrument tray, reusable
U2 Knee MIS case
UNITED ORTHOPEDIC CORP.
9303-8060-RT
In Commercial Distribution

  • 04719872178019 ()
9303-8060-RT

  • Instrument tray, reusable
U2 Knee XUC case
UNITED ORTHOPEDIC CORP.
9303-8053
In Commercial Distribution

  • 04719872178002 ()
9303-8053

  • Instrument tray, reusable
U2 Knee CMA case
UNITED ORTHOPEDIC CORP.
9303-8052
In Commercial Distribution

  • 04719872177999 ()
9303-8052

  • Instrument tray, reusable
U2 Knee case #4
UNITED ORTHOPEDIC CORP.
9303-8040-RT
In Commercial Distribution

  • 04719872177982 ()

  • #4
9303-8040-RT

  • Instrument tray, reusable
U2 Knee case #3
UNITED ORTHOPEDIC CORP.
9303-8030-RT
In Commercial Distribution

  • 04719872177975 ()

  • #3
9303-8030-RT

  • Instrument tray, reusable
Tibial insert trial case
UNITED ORTHOPEDIC CORP.
9303-8029
In Commercial Distribution

  • 04719872177968 ()
9303-8029

  • Instrument tray, reusable
U2 Knee case #2
UNITED ORTHOPEDIC CORP.
9303-8020-RT
In Commercial Distribution

  • 04719872177951 ()

  • #2
9303-8020-RT

  • Instrument tray, reusable
U2 Knee case #1
UNITED ORTHOPEDIC CORP.
9303-8010-RT
In Commercial Distribution

  • 04719872177944 ()

  • #1
9303-8010-RT

  • Instrument tray, reusable
UCP Stem case #2
UNITED ORTHOPEDIC CORP.
9107-8120
In Commercial Distribution

  • 04719872177845 ()
9107-8120

  • Instrument tray, reusable
UCP Stem case #1
UNITED ORTHOPEDIC CORP.
9107-8110
In Commercial Distribution

  • 04719872177838 ()
9107-8110

  • Instrument tray, reusable
U2 Hip case, #3
UNITED ORTHOPEDIC CORP.
9104-8503
In Commercial Distribution

  • 04719872177760 ()
9104-8503

  • Instrument tray, reusable
U2 Hip case, #2
UNITED ORTHOPEDIC CORP.
9104-8502
In Commercial Distribution

  • 04719872177753 ()

  • #2
9104-8502

  • Instrument tray, reusable
U2 Hip case, #1
UNITED ORTHOPEDIC CORP.
9104-8501
In Commercial Distribution

  • 04719872177746 ()

  • #1
9104-8501

  • Instrument tray, reusable
U2 Hip basic case
UNITED ORTHOPEDIC CORP.
9104-8110-RT
In Commercial Distribution

  • 04719872177722 ()
9104-8110-RT

  • Instrument tray, reusable
U2 Knee case #5
UNITED ORTHOPEDIC CORP.
9303-8050
In Commercial Distribution

  • 04719872175339 ()

  • #5
9303-8050

  • Instrument tray, reusable
U2 KNEE Case #4
UNITED ORTHOPEDIC CORP.
9303-8040-RA
In Commercial Distribution

  • 04719872175322 ()
9303-8040-RA

  • Instrument tray, reusable
U2 KNEE Case #3
UNITED ORTHOPEDIC CORP.
9303-8030-RA
In Commercial Distribution

  • 04719872175315 ()
9303-8030-RA

  • Instrument tray, reusable
U2 KNEE Case #2
UNITED ORTHOPEDIC CORP.
9303-8020
In Commercial Distribution

  • 04719872175308 ()
9303-8020

  • Instrument tray, reusable
U2 KNEE Case #1
UNITED ORTHOPEDIC CORP.
9303-8010
In Commercial Distribution

  • 04719872175292 ()
9303-8010

  • Instrument tray, reusable
U2 Knee MIS case
UNITED ORTHOPEDIC CORP.
9303-8060-RA
In Commercial Distribution

  • 04719872175353 ()
9303-8060-RA

  • Instrument tray, reusable
8.5mm Case, Cannulated, Reduction
Pioneer Surgical Technology, Inc.
02-RS-C-85-CASE-E
Not in Commercial Distribution

  • 00846468080167 ()
02-RS-C-85-CASE-E

  • Device sterilization/disinfection container, reusable
4.5mm Case, Cannulated, Reduction
Pioneer Surgical Technology, Inc.
02-RS-C-45-CASE-E
Not in Commercial Distribution

  • 00846468080150 ()
02-RS-C-45-CASE-E

  • Device sterilization/disinfection container, reusable
Implant Case, Cannulated, Reduction
Pioneer Surgical Technology, Inc.
02-RS-C-IMP-CASE-E
Not in Commercial Distribution

  • 00846468080143 ()
02-RS-C-IMP-CASE-E

  • Device sterilization/disinfection container, reusable
Instrument Case, Cannulated, Reduction
Pioneer Surgical Technology, Inc.
02-RS-C-INS-CASE-E
Not in Commercial Distribution

  • 00846468080136 ()
02-RS-C-INS-CASE-E

  • Device sterilization/disinfection container, reusable
8.5mm Case, Cannulated, Polyaxial
Pioneer Surgical Technology, Inc.
02-PA-C-85-CASE-E
Not in Commercial Distribution

  • 00846468080129 ()
02-PA-C-85-CASE-E

  • Device sterilization/disinfection container, reusable
4.5mm Case, Cannulated, Polyaxial
Pioneer Surgical Technology, Inc.
02-PA-C-45-CASE-E
Not in Commercial Distribution

  • 00846468080112 ()
02-PA-C-45-CASE-E

  • Device sterilization/disinfection container, reusable
Instrument Case, Cannulated, Polyaxial
Pioneer Surgical Technology, Inc.
02-PA-C-INS-CASE-E
Not in Commercial Distribution

  • 00846468080099 ()
02-PA-C-INS-CASE-E

  • Device sterilization/disinfection container, reusable
Implant Case, Cannulated, Polyaxial
Pioneer Surgical Technology, Inc.
02-PA-C-IMP-CASE-E
Not in Commercial Distribution

  • 00846468080105 ()
02-PA-C-IMP-CASE-E

  • Device sterilization/disinfection container, reusable
KIT, LOCAL HAND CASE
Cardinal Health 200, LLC
PO35HPBJC
In Commercial Distribution

  • 50888439952733 ()
  • 10888439952735 ()
PO35HPBJC

  • Orthopaedic surgical procedure kit, medicated
CASE 2984004 CAPSTONE PMI
MEDTRONIC SOFAMOR DANEK, INC.
2984004
In Commercial Distribution

  • 00613994438003 ()


  • Instrument tray, reusable
Osteopower 2i Carrying Case
OSTEOMED LLC
450-0511
In Commercial Distribution

  • 00845694012706 ()
450-0511

  • General internal orthopaedic fixation system implantation kit
CASE 7083000 INSTRUMENT TRAY
MEDTRONIC SOFAMOR DANEK, INC.
7083000
In Commercial Distribution

  • 00613994455789 ()


  • Instrument tray, reusable
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