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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ACIF TRIAL 14 X 14 X 05
Corentec Co., Ltd
SI.C10.0021
In Commercial Distribution

  • 08806373870163 ()


  • Spinal implant trial
Guide Driver Sleeve
Corentec Co., Ltd
SI.AP6.0047
In Commercial Distribution

  • 08800068970534 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MIS ROD HOLDER
Corentec Co., Ltd
21805001
In Commercial Distribution

  • 08800068947550 ()


  • Surgical screwdriver, reusable
Bone Traction Needle,130mm
Corentec Co., Ltd
217100070
In Commercial Distribution

  • 08800068943545 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Bone Traction Needle,110mm
Corentec Co., Ltd
217100068
In Commercial Distribution

  • 08800068943521 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Distraction blade,left,130mm
Corentec Co., Ltd
217100061
In Commercial Distribution

  • 08800068943491 ()


  • Surgical retractor/retraction system blade, reusable
Distraction blade,left,110mm
Corentec Co., Ltd
217100059
In Commercial Distribution

  • 08800068943477 ()


  • Surgical retractor/retraction system blade, reusable
Distraction blade,left, 90mm
Corentec Co., Ltd
217100057
In Commercial Distribution

  • 08800068943453 ()


  • Surgical retractor/retraction system blade, reusable
Distraction blade,right,130mm
Corentec Co., Ltd
217100052
In Commercial Distribution

  • 08800068943446 ()


  • Surgical retractor/retraction system blade, reusable
Distraction blade,right,110mm
Corentec Co., Ltd
217100050
In Commercial Distribution

  • 08800068943422 ()


  • Human herpesvirus 7 (HHV7) antigen IVD, control
Distraction blade,right,90mm
Corentec Co., Ltd
217100048
In Commercial Distribution

  • 08800068943408 ()


  • Surgical retractor/retraction system blade, reusable
DLIF Round Scraper14
Corentec Co., Ltd
SI.C40.0103
In Commercial Distribution

  • 08800068964526 ()


  • Bone file/rasp, manual, reusable
DLIF Round Scraper12
Corentec Co., Ltd
SI.C40.0102
In Commercial Distribution

  • 08800068964519 ()


  • Bone file/rasp, manual, reusable
DLIF Round Scraper10
Corentec Co., Ltd
SI.C40.0102
In Commercial Distribution

  • 08800068964502 ()


  • Bone file/rasp, manual, reusable
DLIF Round Scraper 8
Corentec Co., Ltd
SI.C40.0100
In Commercial Distribution

  • 08800068964496 ()


  • Bone file/rasp, manual, reusable
Blunt Distractor 14
Corentec Co., Ltd
SI.C50.2114
In Commercial Distribution

  • 08800068964458 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 13
Corentec Co., Ltd
SI.C50.2113
In Commercial Distribution

  • 08800068964441 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 12
Corentec Co., Ltd
SI.C50.2112
In Commercial Distribution

  • 08800068964434 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 11
Corentec Co., Ltd
SI.C50.2111
In Commercial Distribution

  • 08800068964427 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 10
Corentec Co., Ltd
SI.C50.2110
In Commercial Distribution

  • 08800068964410 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 9
Corentec Co., Ltd
SI.C50.2109
In Commercial Distribution

  • 08800068964403 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 8
Corentec Co., Ltd
SI.C50.2108
In Commercial Distribution

  • 08800068964397 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 14
Corentec Co., Ltd
SI.C50.0114
In Commercial Distribution

  • 08800068964359 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 13
Corentec Co., Ltd
SI.C50.0113
In Commercial Distribution

  • 08800068964342 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 12
Corentec Co., Ltd
SI.C50.0112
In Commercial Distribution

  • 08800068964335 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 11
Corentec Co., Ltd
SI.C50.0111
In Commercial Distribution

  • 08800068964328 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 10
Corentec Co., Ltd
SI.C50.0110
In Commercial Distribution

  • 08800068964311 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 9
Corentec Co., Ltd
SI.C50.0109
In Commercial Distribution

  • 08800068964304 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Shaver 8
Corentec Co., Ltd
SI.C50.0108
In Commercial Distribution

  • 08800068964298 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Guide Wire
Corentec Co., Ltd
SI.MP6.0022
In Commercial Distribution

  • 08800068964281 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Blunt Shaver 7
Corentec Co., Ltd
SI.C50.0107
In Commercial Distribution

  • 08800068964144 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Blunt Distractor 7
Corentec Co., Ltd
SI.C50.2107
In Commercial Distribution

  • 08800068964120 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MIS ANTI TORQUE HANDLE
Corentec Co., Ltd
SI.MP6.0016
In Commercial Distribution

  • 08800068964113 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Guide Breaker
Corentec Co., Ltd
SI.AP6.0057
In Commercial Distribution

  • 08800068962638 ()


  • Internal spinal fixation procedure kit, reusable
MIS Dilator
Corentec Co., Ltd
SI.MP6.0021
In Commercial Distribution

  • 08800068961747 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Rod Bender
Corentec Co., Ltd
23801100
In Commercial Distribution

  • 08800068961402 ()


  • Manual orthopaedic bender, reusable
DLIF cage guide sleeve inserter W22 outer sheath
Corentec Co., Ltd
SI.C40.0010
In Commercial Distribution

  • 08800068960320 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
DLIF cage guide sleeve inserter for W18
Corentec Co., Ltd
SI.C40.0009
In Commercial Distribution

  • 08800068960313 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Bone Rasp, Straight
Corentec Co., Ltd
213210028
In Commercial Distribution

  • 08800068960306 ()


  • Bone file/rasp, manual, reusable
TLIF HOLDER, PISTOL GRIP
Corentec Co., Ltd
SI.C30.0014
In Commercial Distribution

  • 08800068960283 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Rod Holder
Corentec Co., Ltd
SI.AP6.0052
In Commercial Distribution

  • 08800068960184 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quick Coupling T-Handle, Ratcheting
Corentec Co., Ltd
212060107
In Commercial Distribution

  • 08800068956934 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quick Coupling I-Handle, Ratcheting
Corentec Co., Ltd
212060106
In Commercial Distribution

  • 08800068956927 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Distractor
Corentec Co., Ltd
217100079
In Commercial Distribution

  • 08800068943590 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Bone Traction Needle,120mm
Corentec Co., Ltd
217100069
In Commercial Distribution

  • 08800068943538 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Bone Traction Needle,100mm
Corentec Co., Ltd
217100067
In Commercial Distribution

  • 08800068943514 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Bone Traction Needle,90mm
Corentec Co., Ltd
217100066
In Commercial Distribution

  • 08800068943507 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Distraction blade,left,120mm
Corentec Co., Ltd
217100060
In Commercial Distribution

  • 08800068943484 ()


  • Surgical retractor/retraction system blade, reusable
Distraction blade,left,100mm
Corentec Co., Ltd
217100058
In Commercial Distribution

  • 08800068943460 ()


  • Surgical retractor/retraction system blade, reusable
Distraction blade,right,120mm
Corentec Co., Ltd
217100051
In Commercial Distribution

  • 08800068943439 ()


  • Human herpesvirus 7 (HHV7) antigen IVD, control
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