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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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N/A - 00613994990853

CASE 2000027 LEVEL 3
MEDTRONIC SOFAMOR DANEK, INC.
2000027
In Commercial Distribution

  • 00613994990853 ()


  • Instrument tray, reusable

N/A - 00613994990846

CASE 2000026 LEVEL 2
MEDTRONIC SOFAMOR DANEK, INC.
2000026
In Commercial Distribution

  • 00613994990846 ()


  • Instrument tray, reusable

N/A - 00613994990839

CASE 2000025 LEVEL 1
MEDTRONIC SOFAMOR DANEK, INC.
2000025
In Commercial Distribution

  • 00613994990839 ()


  • Instrument tray, reusable

N/A - 00613994978240

PERIMETER 3499006 OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
3499006
In Commercial Distribution

  • 00613994978240 ()


  • Instrument tray, reusable

OsteoMed - 00845694034524

Carrying Case OsteoMed Multiproduct
OSTEOMED LLC
220-0508
In Commercial Distribution

  • 00845694034524 ()
220-0508

  • General internal orthopaedic fixation system implantation kit

N/A - 00613994647511

CASE 9010000154 PRE-ASSEMBLED 3DX
MEDTRONIC SOFAMOR DANEK, INC.
9010000154
In Commercial Distribution

  • 00613994647511 ()


  • Instrument tray, reusable

SCANLAN® V.I.P™ Instrument Sterilization Trays - 00846159010947

replacement soft-sided carrying case
SCANLAN INTERNATIONAL INC
8008-64
In Commercial Distribution

  • 00846159010947 ()
8008-64

  • Device sterilization/disinfection container, reusable

SCANLAN® V.I.P™ Instrument Sterilization Trays - 00846159010923

Without soft-sided carrying case
SCANLAN INTERNATIONAL INC
8008-62
In Commercial Distribution

  • 00846159010923 ()
8008-62

  • Device sterilization/disinfection container, reusable

UTS Hip Stem - 04711605582933

UTS Stem, case #2
UNITED ORTHOPEDIC CORP.
9116-8102-RA
In Commercial Distribution

  • 04711605582933 ()
9116-8102-RA

  • Instrument tray, reusable

UTS Hip Stem - 04711605582926

UTS Stem, case #1
UNITED ORTHOPEDIC CORP.
9116-8101-RA
In Commercial Distribution

  • 04711605582926 ()
9116-8101-RA

  • Instrument tray, reusable

UCP Stem - 04711605582766

UCP Stem case #2
UNITED ORTHOPEDIC CORP.
9107-8120-RA
In Commercial Distribution

  • 04711605582766 ()
9107-8120-RA

  • Instrument tray, reusable

Quantum® Spinal Fixation System - 00846468020842

INSTRUMENT CASE, LUMBAR, SECONDARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-S
Not in Commercial Distribution

  • 00846468020842 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468020835

INSTRUMENT CASE, LUMBAR, PRIMARY
Pioneer Surgical Technology, Inc.
10-INSTCASE-P
Not in Commercial Distribution

  • 00846468020835 ()


  • General internal orthopaedic fixation system implantation kit

Conformity Stem - 04711605587082

Hip stem basic case
UNITED ORTHOPEDIC CORP.
9110-8102
In Commercial Distribution

  • 04711605587082 ()
9110-8102

  • Instrument tray, reusable

UTF Hip Stem - 04711605585330

Hip stem basic case
UNITED ORTHOPEDIC CORP.
9106-8702
In Commercial Distribution

  • 04711605585330 ()
9106-8702

  • Instrument tray, reusable

Streamline® OCT Occipito-Cervico-Thoracic System - 00846468027377

INSTRUMENT CASE, CERVICO THORACIC
Pioneer Surgical Technology, Inc.
23-INSTCASE
Not in Commercial Distribution

  • 00846468027377 ()


  • General internal orthopaedic fixation system implantation kit

Streamline® TL Spinal Fixation System - 00846468006846

TRIPLE LAYER CASE BASE
Pioneer Surgical Technology, Inc.
02-CASE-TLBASE
Not in Commercial Distribution

  • 00846468006846 ()
02-CASE-TLBASE

  • Device sterilization/disinfection container, reusable

Streamline® TL Spinal Fixation System - 00846468006839

SINGLE LAYER CASE BASE
Pioneer Surgical Technology, Inc.
02-CASE-SLBASE
Not in Commercial Distribution

  • 00846468006839 ()
02-CASE-SLBASE

  • Device sterilization/disinfection container, reusable

Streamline® TL Spinal Fixation System - 00846468006747

DOUBLE LAYER CASE BASE
Pioneer Surgical Technology, Inc.
02-CASE-DLBASE
Not in Commercial Distribution

  • 00846468006747 ()
02-CASE-DLBASE

  • Device sterilization/disinfection container, reusable

PYRAMESH® C Titanium Mesh - 00673978081274

CASE 905-895 PYRAMESH INSTRUMENT
MEDTRONIC SOFAMOR DANEK, INC.
905-895
In Commercial Distribution

  • 00673978081274 ()


  • Instrument tray, reusable
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