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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Cochlear Nucleus LiteWear Case
COCHLEAR LIMITED
Z327613
In Commercial Distribution

  • 09321502024655 ()
Z327613

  • Cochlear implant/auditory brainstem implant sound processor off-ear holder
SMALL CASE CUSTOM PREFERRED
Cardinal Health 200, LLC
SBA63SCST3
In Commercial Distribution

  • 50888439206225 ()
  • 10888439206227 ()
SBA63SCST3

  • General surgical procedure kit, non-medicated, single-use
HERNIA REPAIR CASE PACK
Cardinal Health 200, LLC
SBA42HRMSD
In Commercial Distribution

  • 50888439158623 ()
  • 10888439158625 ()
SBA42HRMSD

  • General surgical procedure kit, medicated
UPPER EXTREMITY HAND CASE
MEDLINE INDUSTRIES, INC.
DYNJ40597C
In Commercial Distribution

  • 40193489974226 ()
  • 10193489974225 ()
DYNJ40597C

  • General surgical procedure kit, non-medicated, single-use
AA BROACH CASE ASSY
SYMMETRY MEDICAL INC.
25-054-000
In Commercial Distribution

  • 00847538011203 ()
259807025

  • Device sterilization/disinfection container, reusable
AA INSTRUMENT CASE LID
SYMMETRY MEDICAL INC.
25-051-001
In Commercial Distribution

  • 00847538011197 ()
259807022

  • Device sterilization/disinfection container, reusable
AA INSTRUMENT CASE TRAY
SYMMETRY MEDICAL INC.
25-051-002
In Commercial Distribution

  • 00847538011005 ()
259807021

  • Device sterilization/disinfection container, reusable
AA INSTRUMENT CASE OUTER
SYMMETRY MEDICAL INC.
25-051-003
In Commercial Distribution

  • 00847538010985 ()
259807020

  • Device sterilization/disinfection container, reusable
AA BROACH CASE OUTER
SYMMETRY MEDICAL INC.
25-054-001
In Commercial Distribution

  • 00847538011340 ()
259807027

  • Device sterilization/disinfection container, reusable
AA BROACH CASE LID
SYMMETRY MEDICAL INC.
25-054-002
In Commercial Distribution

  • 00847538011357 ()
259807028

  • Device sterilization/disinfection container, reusable
L4/L5 INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
38-L45-FUSION
Not in Commercial Distribution

  • 00846468040345 ()
38-L45-FUSION

  • General internal orthopaedic fixation system implantation kit
Songer Cable Instrument Case
Pioneer Surgical Technology, Inc.
986.1
Not in Commercial Distribution

  • 00846468047962 ()


  • Internal spinal fixation system cable
MIS POSTERIOR RETRACTOR CASE
Pioneer Surgical Technology, Inc.
53-POSTRETR
Not in Commercial Distribution

  • 00846468044879 ()


  • General internal orthopaedic fixation system implantation kit
Hip stem basic case
UNITED ORTHOPEDIC CORP.
9110-8102
In Commercial Distribution

  • 04711605587082 ()
9110-8102

  • Instrument tray, reusable
Hip stem basic case
UNITED ORTHOPEDIC CORP.
9106-8702
In Commercial Distribution

  • 04711605585330 ()
9106-8702

  • Instrument tray, 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
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
Pocket Resuscitator white case
FOREMOUNT ENTERPRISE CO., LTD.
ME6201
In Commercial Distribution

  • 04719871890691 ()


  • Resuscitator face mask, single-use
SMALL CASE CUSTOM PREFERRED
Cardinal Health 200, LLC
SBA63SCST5
In Commercial Distribution

  • 50888439728543 ()
  • 10888439728545 ()
SBA63SCST5

  • General surgical procedure kit, non-medicated, single-use
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
UPPER EXTREMITY HAND CASE
MEDLINE INDUSTRIES, INC.
DYNJ40597B
In Commercial Distribution

  • 40193489294010 ()
  • 10193489294019 ()
DYNJ40597B

  • General surgical procedure kit, non-medicated, single-use
Glenosphere Trials Case Lid
TORNIER, INC.
NCR262
In Commercial Distribution

  • 00846832065806 ()
NCR262

  • 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
Trial Head Case Lid
TORNIER, INC.
9722916
In Commercial Distribution

  • 00846832023813 ()
9722916

  • Instrument tray, reusable
Trial Head Case Base
TORNIER, INC.
9722915
In Commercial Distribution

  • 00846832023806 ()
9722915

  • Instrument tray, reusable
Humeral Instrument Case Lid
TORNIER
NCR252
In Commercial Distribution

  • 00846832020607 ()
NCR252

  • Instrument tray, reusable
Reversed Revision Case Lid
TORNIER
NCR030
In Commercial Distribution

  • 00846832019410 ()
NCR030

  • Instrument tray, reusable
Trial Head Case Lid
TORNIER, INC.
9722912
In Commercial Distribution

  • 00846832015948 ()
9722912

  • Instrument tray, reusable
Trial Head Case Base
TORNIER, INC.
9722911
In Commercial Distribution

  • 00846832015931 ()
9722911

  • Instrument tray, reusable
INSTRUMENT CASE 2, EMPTY
Pioneer Surgical Technology, Inc.
04-SLMIS-INS-2-EMP
Not in Commercial Distribution

  • 00846468064143 ()
04-SLMIS-INS-2-EMP

  • General internal orthopaedic fixation system implantation kit
INSTRUMENT CASE 1, EMPTY
Pioneer Surgical Technology, Inc.
04-SLMIS-INS-1-EMP
Not in Commercial Distribution

  • 00846468064136 ()
04-SLMIS-INS-1-EMP

  • General internal orthopaedic fixation system implantation kit
8.5mm AUXILIARY CASE, EMPTY
Pioneer Surgical Technology, Inc.
04-SLMIS-85AUX-EMP
Not in Commercial Distribution

  • 00846468060206 ()
04-SLMIS-85AUX-EMP

  • General internal orthopaedic fixation system implantation kit
4.5mm AUXILIARY CASE, EMPTY
Pioneer Surgical Technology, Inc.
04-SLMIS-45AUX-EMP
Not in Commercial Distribution

  • 00846468060190 ()
04-SLMIS-45AUX-EMP

  • General internal orthopaedic fixation system implantation kit
FUSION MIS Instrument Case
Pioneer Surgical Technology, Inc.
29-MISFUSION
Not in Commercial Distribution

  • 00846468060718 ()


  • General internal orthopaedic fixation system implantation kit
STERILIZATION CASE, 3.5mm/ 4.0mm
Pioneer Surgical Technology, Inc.
00-1147-035-01
In Commercial Distribution

  • 00846468073992 ()
00-1147-035-01

  • Device sterilization/disinfection container, reusable
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 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
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