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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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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

Fixcet Spinal Facet Screw System - M697X06300021

FIXCET STERILIZATION CASE
Xtant Medical Holdings, Inc.
X063-0002
In Commercial Distribution

  • M697X06300020 ()
  • M697X06300021 ()


  • Device sterilization/disinfection container, reusable

Silex Sacroiliac Joint Fusion System - M697X07900031

STERILIZATION CASE, SILEX
Xtant Medical Holdings, Inc.
X079-0003
In Commercial Distribution

  • M697X07900030 ()
  • M697X07900031 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

X-port Minimally Invasive Set - M697X01400151

X-PORT, Sterilization Case
Xtant Medical Holdings, Inc.
X014-0015
In Commercial Distribution

  • M697X01400150 ()
  • M697X01400151 ()


  • Bone-screw internal spinal fixation system, non-sterile

Calix Spinal Implant System - M697X00300021

Calix Sterilization Case
Xtant Medical Holdings, Inc.
X003-0002
In Commercial Distribution

  • M697X00300020 ()
  • M697X00300021 ()


  • Polymeric spinal interbody fusion cage

Medline Industries, Inc. - 10888277764781

OPEN CASE PACK
MEDLINE INDUSTRIES, INC.
DYNJ59637
In Commercial Distribution

  • 10888277764781 ()
  • 40888277764782 ()
DYNJ59637

  • General surgical procedure kit, non-medicated, single-use

CastleLoc Pectus Bar System Instrument Set - 08809986460493

Implant Case - Caddy
L&K BIOMED CO. ,LTD.
PB05-8007
In Commercial Distribution

  • 08809986460493 ()
PB05-8007

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460486

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

  • 08809986460486 ()
PB05-8006

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460479

Implant Case - Tray3
L&K BIOMED CO. ,LTD.
PB05-8005
In Commercial Distribution

  • 08809986460479 ()
PB05-8005

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460462

Implant Case - Tray2
L&K BIOMED CO. ,LTD.
PB05-8004
In Commercial Distribution

  • 08809986460462 ()
PB05-8004

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460455

Implant Case - Tray1
L&K BIOMED CO. ,LTD.
PB05-8003
In Commercial Distribution

  • 08809986460455 ()
PB05-8003

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460448

Implant Case - Container
L&K BIOMED CO. ,LTD.
PB05-8002
In Commercial Distribution

  • 08809986460448 ()
PB05-8002

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460431

Implant Case - Cover
L&K BIOMED CO. ,LTD.
PB05-8001
In Commercial Distribution

  • 08809986460431 ()
PB05-8001

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medline Industries, Inc. - 10888277560635

GENERAL LAP CASE
MEDLINE INDUSTRIES, INC.
DYNJ901231
In Commercial Distribution

  • 10888277560635 ()
DYNJ901231

  • General surgical procedure kit, non-medicated, reusable

CARDINAL HEALTH - 10888439167740

PUMP CASE PACK
Cardinal Health 200, LLC
SCV13PCBCF
In Commercial Distribution

  • 50888439167748 ()
  • 10888439167740 ()
SCV13PCBCF

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

BIXCUT - 04546540145406

Reamer Case II
Stryker GmbH
0225-8000
In Commercial Distribution

  • 04546540145406 ()
0225-8000

  • Instrument tray, reusable

BIXCUT - 04546540145314

Reamer Case I
Stryker GmbH
0225-6000
In Commercial Distribution

  • 04546540145314 ()
0225-6000

  • Instrument tray, reusable

b-ONE™ Primary Acetabular System - 00843575104151

Acetabular Sterilization Case
B-ONE ORTHO, CORP.
8819900200
In Commercial Distribution

  • 00843575104151 ()
8819900200

  • Surgical instrument/implant rack

b-ONE™ Primary Acetabular System - 00843575104144

Sterilization Case Lid
B-ONE ORTHO, CORP.
8819900000
In Commercial Distribution

  • 00843575104144 ()
8819900000

  • Surgical instrument/implant rack

Imola-Silverstone - 00843210133669

Sterilization Case- Silverstone
Altus Spine, LLC
700-1100
In Commercial Distribution

  • 00843210133669 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Suzuka Interbody Fusion System - 00843210133379

Suzuka Sterilization Case
Altus Spine, LLC
210-2000
In Commercial Distribution

  • 00843210133379 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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