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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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Irix-C Cervical Integrated Fusion System - M697X06600031

Implant Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0003
In Commercial Distribution

  • M697X06600030 ()
  • M697X06600031 ()


  • Polymeric spinal interbody fusion cage

NAR Kit - 00842209121120

KIT, CUSTOM HARD CASE
NORTH AMERICAN RESCUE, LLC
85-3592
In Commercial Distribution

  • 00842209121120 ()
85-3592

  • First aid kit, medicated

LnK Spinal Instrument System - 08809986460820

65 Screw Case Cover
L&K BIOMED CO. ,LTD.
LS03-8010
In Commercial Distribution

  • 08809986460820 ()
LS03-8010

  • Orthopaedic prosthesis implantation positioning instrument, reusable

LnK Spinal Instrument System - 08809986460837

85 Screw Case Cover
L&K BIOMED CO. ,LTD.
LS03-8011
In Commercial Distribution

  • 08809986460837 ()
LS03-8011

  • Orthopaedic prosthesis implantation positioning instrument, reusable

LnK Spinal Instrument System - 08809986460813

55 Screw Case Cover
L&K BIOMED CO. ,LTD.
LS03-8009
In Commercial Distribution

  • 08809986460813 ()
LS03-8009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460509

Implant Case - Caddy (removal)
L&K BIOMED CO. ,LTD.
PB05-8008
In Commercial Distribution

  • 08809986460509 ()
PB05-8008

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460394

Basic Instrument Case - Container
L&K BIOMED CO. ,LTD.
PB05-1002
In Commercial Distribution

  • 08809986460394 ()
PB05-1002

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CastleLoc Pectus Bar System Instrument Set - 08809986460387

Basic Instrument Case - Cover
L&K BIOMED CO. ,LTD.
PB05-1001
In Commercial Distribution

  • 08809986460387 ()
PB05-1001

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100277

Davida Univ. Retractor Case
FLEXBAR MACHINE CORPORATION
69801
In Commercial Distribution

  • 00842102100277 ()
69801

  • Neurosurgical retractor, self-retaining

REX - 08809375717061

Dio Acp System Case
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375717061 ()
RC.IN.0021

  • Spinal fixation plate, non-bioabsorbable
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