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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Implant Case - Tray4
L&K BIOMED CO. ,LTD.
PB05-8006
In Commercial Distribution

  • 08809986460486 ()
PB05-8006

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Implant Case - Tray3
L&K BIOMED CO. ,LTD.
PB05-8005
In Commercial Distribution

  • 08809986460479 ()
PB05-8005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Implant Case - Tray2
L&K BIOMED CO. ,LTD.
PB05-8004
In Commercial Distribution

  • 08809986460462 ()
PB05-8004

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Implant Case - Tray1
L&K BIOMED CO. ,LTD.
PB05-8003
In Commercial Distribution

  • 08809986460455 ()
PB05-8003

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Implant Case - Container
L&K BIOMED CO. ,LTD.
PB05-8002
In Commercial Distribution

  • 08809986460448 ()
PB05-8002

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Implant Case - Cover
L&K BIOMED CO. ,LTD.
PB05-8001
In Commercial Distribution

  • 08809986460431 ()
PB05-8001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
OPEN CASE PACK
MEDLINE INDUSTRIES, INC.
DYNJ59637
In Commercial Distribution

  • 10888277764781 ()
  • 40888277764782 ()
DYNJ59637

  • General surgical procedure kit, non-medicated, single-use
DENTAL CASE SUPPLIES
MEDLINE INDUSTRIES, INC.
DYKM1156
In Commercial Distribution

  • 10888277832657 ()
DYKM1156

  • General surgical procedure kit, non-medicated, reusable
QuickFix MMF Case
OSTEOMED LLC
220-9003
In Commercial Distribution

  • 00842528110959 ()
220-9003

  • Instrument tray, reusable
PUMP CASE PACK
Cardinal Health 200, LLC
SCV13PCBC2
In Commercial Distribution

  • 50888439142974 ()
  • 10888439142976 ()
SCV13PCBC2

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
Sterilization Case 1
Altus Spine, LLC
1020-1000
In Commercial Distribution

  • 00843210186849 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
PUMP CASE PACK
Cardinal Health 200, LLC
SCV13PCBC1
In Commercial Distribution

  • 50888439061183 ()
  • 10888439061185 ()
SCV13PCBC1

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
Fracture Case Lid
TORNIER, INC.
NCR10412
In Commercial Distribution

  • 00846832093564 ()
NCR10412

  • Instrument tray, reusable
Auxilary Case Lid
TORNIER, INC.
NCR272
In Commercial Distribution

  • 00846832071814 ()
NCR272

  • Instrument tray, reusable
Auxiliary Case Base
TORNIER, INC.
NBR272
In Commercial Distribution

  • 00846832071807 ()
NBR272

  • Instrument tray, reusable
Tray; 32/case
SAKURA FINETEK U.S.A., INC.
3981
In Commercial Distribution

  • 00615233013279 ()
3981

  • Microscope slide tray
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
U2 Stem case
UNITED ORTHOPEDIC CORP.
9104-8120
In Commercial Distribution

  • 04719872172413 ()
9104-8120

  • Instrument tray, reusable
Case U2 Cup
UNITED ORTHOPEDIC CORP.
9104-8020
In Commercial Distribution

  • 04719872172352 ()
9104-8020

  • Instrument tray, reusable
PUMP CASE PACK
MEDLINE INDUSTRIES, INC.
DYNJ63701A
In Commercial Distribution

  • 10193489326444 ()
DYNJ63701A

  • General surgical procedure kit, non-medicated, single-use
AA CASE ASSEMBLY
SYMMETRY MEDICAL INC.
25-051-000
In Commercial Distribution

  • 00847538010718 ()
259807023

  • Device sterilization/disinfection container, reusable
U2 Bipolar Case
UNITED ORTHOPEDIC CORP.
9204-8040
In Commercial Distribution

  • 04719872179269 ()
9204-8040

  • Instrument tray, reusable
PSA Case #5
UNITED ORTHOPEDIC CORP.
9303-8075
In Commercial Distribution

  • 04719872178088 ()
9303-8075

  • Instrument tray, reusable
PSA Case #4
UNITED ORTHOPEDIC CORP.
9303-8074
In Commercial Distribution

  • 04719872178071 ()
9303-8074

  • Instrument tray, reusable
PSA Case #3
UNITED ORTHOPEDIC CORP.
9303-8073-RA
In Commercial Distribution

  • 04719872178064 ()

  • #3
9303-8073-RA

  • Instrument tray, reusable
PSA Case #3
UNITED ORTHOPEDIC CORP.
9303-8073
In Commercial Distribution

  • 04719872178057 ()
9303-8073

  • Instrument tray, reusable
PSA Case #2
UNITED ORTHOPEDIC CORP.
9303-8072
In Commercial Distribution

  • 04719872178040 ()
9303-8072

  • Instrument tray, reusable
PSA Case #1
UNITED ORTHOPEDIC CORP.
9303-8071-RA
In Commercial Distribution

  • 04719872178033 ()
9303-8071-RA

  • Instrument tray, reusable
U2 Bipolar case
UNITED ORTHOPEDIC CORP.
9204-8041-RT
In Commercial Distribution

  • 04719872177890 ()
9204-8041-RT

  • Instrument tray, reusable
U2 Bipolar case
UNITED ORTHOPEDIC CORP.
9204-8041-RC
In Commercial Distribution

  • 04719872177883 ()
9204-8041-RC

  • Instrument tray, reusable
U2 XPE case
UNITED ORTHOPEDIC CORP.
9204-8020
In Commercial Distribution

  • 04719872177876 ()
9204-8020

  • Instrument tray, reusable
U2 Acetabular case
UNITED ORTHOPEDIC CORP.
9203-8310-RT
In Commercial Distribution

  • 04719872177869 ()
9203-8310-RT

  • Instrument tray, reusable
Acetabular MIS case
UNITED ORTHOPEDIC CORP.
9203-8102-RC
In Commercial Distribution

  • 04719872177852 ()
9203-8102-RC

  • Instrument tray, reusable
U2 Stem case
UNITED ORTHOPEDIC CORP.
9104-8120-RT
In Commercial Distribution

  • 04719872177739 ()
9104-8120-RT

  • Instrument tray, reusable
PSA Reamer case
UNITED ORTHOPEDIC CORP.
9303-8076
In Commercial Distribution

  • 04719872175360 ()
9303-8076

  • Instrument tray, 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-STRM-IMP-CASE-E
Not in Commercial Distribution

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

  • 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
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
CASE 1859002 EXTRAS
MEDTRONIC SOFAMOR DANEK, INC.
1859002
In Commercial Distribution

  • 00613994410665 ()


  • Instrument tray, reusable
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUS2
In Commercial Distribution

  • 50888439470213 ()
  • 10888439470215 ()
SBA41PCUS2

  • General surgical procedure kit, medicated
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUSD
In Commercial Distribution

  • 50888439515440 ()
  • 10888439515442 ()
SBA41PCUSD

  • General surgical procedure kit, medicated
Single Compartment Case
OSTEOMED LLC
220-0622
In Commercial Distribution

  • 00845694034616 ()
220-0622

  • General internal orthopaedic fixation system implantation kit
Sterilization/Storage Case
SCANLAN INTERNATIONAL INC
9009-979
In Commercial Distribution

  • 00846159021455 ()
9009-979

  • Surgical/emergency suction cannula, non-illuminating, reusable
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUS3
In Commercial Distribution

  • 50888439543085 ()
  • 10888439543087 ()
SBA41PCUS3

  • General surgical procedure kit, medicated
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