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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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CLARITY ® RETRACTOR SYSTEM - 00846468044664

MIS ACCESS CASE
Pioneer Surgical Technology, Inc.
53-MIS-ACCESS
Not in Commercial Distribution

  • 00846468044664 ()


  • General internal orthopaedic fixation system implantation kit

CLARITY ® RETRACTOR SYSTEM - 00846468044312

MIS ARM CASE
Pioneer Surgical Technology, Inc.
53-ARMCASE
Not in Commercial Distribution

  • 00846468044312 ()


  • General internal orthopaedic fixation system implantation kit

Fusion™ Posterior Instrument Set - 00846468032036

LORDOTIC SHAVER CASE
Pioneer Surgical Technology, Inc.
30-LSHAVECASE
Not in Commercial Distribution

  • 00846468032036 ()
30-LSHAVECASE

  • General internal orthopaedic fixation system implantation kit

Tissue-Tek® Lab Aid® Ultra™ II - 00615233013279

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

  • 00615233013279 ()
3981

  • Microscope slide tray

Conformity Stem - 04711605587099

Conformity MIS case
UNITED ORTHOPEDIC CORP.
9110-8103
In Commercial Distribution

  • 04711605587099 ()
9110-8103

  • Instrument tray, reusable

Conformity Stem - 04711605587075

Conformity stem case
UNITED ORTHOPEDIC CORP.
9110-8101
In Commercial Distribution

  • 04711605587075 ()
9110-8101

  • Instrument tray, reusable

Streamline® OCT Occipito-Cervico-Thoracic System - 00846468054588

IMPLANT / INSTRUMENT CASE
Xtant Medical Holdings, Inc.
26-STRMOCT-CASE
Not in Commercial Distribution

  • 00846468054588 ()


  • General internal orthopaedic fixation system implantation kit

PAC Plate® Anterior Cervical Plate System - 00846468024659

DRILL GUIDE CASE
Pioneer Surgical Technology, Inc.
20-GUIDECASE
Not in Commercial Distribution

  • 00846468024659 ()
20-GUIDECASE

  • Device sterilization/disinfection container, reusable

CLARITY® LATERAL RETRACTOR SYSTEM - 00846468010393

RIGID ARM CASE
Pioneer Surgical Technology, Inc.
38-ARM-CASE
Not in Commercial Distribution

  • 00846468010393 ()


  • General internal orthopaedic fixation system implantation kit

Streamline® TL Spinal Fixation System - 00846468006860

CROSSLINK CASE TAG
Pioneer Surgical Technology, Inc.
02-CASE-XLNKTAG
Not in Commercial Distribution

  • 00846468006860 ()
02-CASE-XLNKTAG

  • Device sterilization/disinfection container, reusable

Streamline® TL Spinal Fixation System - 00846468006785

INSTRUMENT CASE TAG
Pioneer Surgical Technology, Inc.
02-CASE-INSTAG
Not in Commercial Distribution

  • 00846468006785 ()
02-CASE-INSTAG

  • Device sterilization/disinfection container, reusable

Zimmer® Cannulated Screw System - 00846468074401

STERILIZATION CASE, 7.5mm
Pioneer Surgical Technology, Inc.
00-1147-075-01
In Commercial Distribution

  • 00846468074401 ()
00-1147-075-01

  • Device sterilization/disinfection container, reusable

Zimmer® Cannulated Screw System - 00846468074340

STERILIZATION CASE, 7.0mm
Pioneer Surgical Technology, Inc.
00-1147-070-01
In Commercial Distribution

  • 00846468074340 ()
00-1147-070-01

  • Device sterilization/disinfection container, reusable

Zimmer® Cannulated Screw System - 00846468074296

STERILIZATION CASE, 6.5mm
Pioneer Surgical Technology, Inc.
00-1147-065-01
In Commercial Distribution

  • 00846468074296 ()
00-1147-065-01

  • Device sterilization/disinfection container, reusable

Zimmer® Cannulated Screw System - 00846468074210

STERILIZATION CASE, 5.5mm
Pioneer Surgical Technology, Inc.
00-1147-055-01
In Commercial Distribution

  • 00846468074210 ()
00-1147-055-01

  • Device sterilization/disinfection container, reusable

Zimmer® Cannulated Screw System - 00846468074098

STERILIZATION CASE, 4.5mm
Pioneer Surgical Technology, Inc.
00-1147-045-01
In Commercial Distribution

  • 00846468074098 ()
00-1147-045-01

  • Device sterilization/disinfection container, reusable

Zimmer® Cannulated Screw System - 00846468073947

STERILIZATION CASE, 3.0mm
Pioneer Surgical Technology, Inc.
00-1147-030-01
In Commercial Distribution

  • 00846468073947 ()
00-1147-030-01

  • Device sterilization/disinfection container, reusable

PACK™ - 00846468063627

PACK Instrument Case
Pioneer Surgical Technology, Inc.
PAC-A1400
Not in Commercial Distribution

  • 00846468063627 ()


  • General internal orthopaedic fixation system implantation kit

Zyfix Spinal Facet Screw System - M697X07600031

Sterilization Case, Zygafix
Xtant Medical Holdings, Inc.
X076-0003
In Commercial Distribution

  • M697X07600030 ()
  • M697X07600031 ()


  • Device sterilization/disinfection container, reusable

Xpress Minimally Invasive Pedicle Screw System - M697X07300081

Sterilization Case, Xpress
Xtant Medical Holdings, Inc.
X073-0008
In Commercial Distribution

  • M697X07300080 ()
  • M697X07300081 ()


  • Device sterilization/disinfection container, reusable
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