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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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Pre-Bent Rod Case
Xtant Medical Holdings, Inc.
26-STRMOCT-PBRD
Not in Commercial Distribution

  • 00846468000349 ()
26-STRMOCT-PBRD

  • Device sterilization/disinfection container, reusable
Option Case 2
Xtant Medical Holdings, Inc.
26-STRMOCT-OPT2
Not in Commercial Distribution

  • 00846468000332 ()
26-STRMOCT-OPT2

  • Device sterilization/disinfection container, reusable
Occipital Case 2
Xtant Medical Holdings, Inc.
26-STRMOCT-OCP2
Not in Commercial Distribution

  • 00846468000318 ()
26-STRMOCT-OCP2

  • 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
Instrument Case 2
Xtant Medical Holdings, Inc.
26-STRMOCT-INS2
Not in Commercial Distribution

  • 00846468000295 ()
26-STRMOCT-INS2

  • Device sterilization/disinfection container, reusable
RIGID ARM CASE
Pioneer Surgical Technology, Inc.
38-ARM-CASE
Not in Commercial Distribution

  • 00846468010393 ()


  • General internal orthopaedic fixation system implantation kit
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
DRILL GUIDE CASE
Pioneer Surgical Technology, Inc.
20-GUIDECASE
Not in Commercial Distribution

20-GUIDECASE

  • 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
IMPLANT CASE, LUMBAR
Pioneer Surgical Technology, Inc.
10-IMPCASE
Not in Commercial Distribution

10-IMPCASE

  • General internal orthopaedic fixation system implantation kit
Conformity MIS case
UNITED ORTHOPEDIC CORP.
9110-8103
In Commercial Distribution

  • 04711605587099 ()
9110-8103

  • Instrument tray, reusable
Conformity stem case
UNITED ORTHOPEDIC CORP.
9110-8101
In Commercial Distribution

  • 04711605587075 ()
9110-8101

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

  • 04713616092814 ()
  • 04713616093491 ()


  • Alternating-pressure bed mattress overlay system
IMPLANT / INSTRUMENT CASE
Xtant Medical Holdings, Inc.
26-STRMOCT-CASE
Not in Commercial Distribution

  • 00846468054588 ()


  • General internal orthopaedic fixation system implantation kit
Instrument Case Echo
Pioneer Surgical Technology, Inc.
PAC-A2400
Not in Commercial Distribution

  • 00846468003951 ()
PAC-A2400

  • Device sterilization/disinfection container, reusable
Instrument Case Delta
Pioneer Surgical Technology, Inc.
PAC-A2300
Not in Commercial Distribution

  • 00846468003944 ()
PAC-A2300

  • Device sterilization/disinfection container, reusable
CASE, ROD CUTTER
Xtant Medical Holdings, Inc.
10-CUTTERCASE
Not in Commercial Distribution

10-CUTTERCASE

  • Device sterilization/disinfection container, reusable
CROSSLINK CASE TAG
Pioneer Surgical Technology, Inc.
02-CASE-XLNKTAG
Not in Commercial Distribution

  • 00846468006860 ()
02-CASE-XLNKTAG

  • Device sterilization/disinfection container, reusable
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