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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Tissue Splitter
LINKSPINE, INC.
80-4730
In Commercial Distribution

  • 00817329023302 ()
80-4730

  • Bone-screw internal spinal fixation system, non-sterile
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2310
In Commercial Distribution

  • 30607915129935 ()


  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2825
In Commercial Distribution

  • 30607915135455 ()


  • Laparoscopic irrigation/aspiration cannula
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX C8XX2, GELPORT 120MM CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2813
In Commercial Distribution

  • 30607915135189 ()


  • Laparoscopic multi-instrument access port, single-use
  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C4119, 32CM GRASPER REPOS CART, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2681
In Commercial Distribution

  • 30607915133970 ()


  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C4119, 32CM GRASPER REPOS CART, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2680
In Commercial Distribution

  • 30607915133963 ()


  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C4120, 38CM GRASPER REPOS CART, 10/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2541
In Commercial Distribution

  • 30607915132737 ()


  • Rigid endoscopic grasping forceps, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2321
In Commercial Distribution

  • 30607915129942 ()


  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CD001, 10mm RETRIEVAL SYSTEM, 10/BX C0R83,12x60 Kii® OPT ZTHR 6/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
CK378
In Commercial Distribution

  • 30607915127795 ()


  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Tissue extraction bag
  • Laparoscopic multi-instrument access port, single-use
  • Ligation clip, metallic
Kit Contains: CFF73, 12x100 Kii Fios ADVFIX 6/BX CFS22, 12x100 Kii SLEEVE ADVFIX 12/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK249
In Commercial Distribution

  • 20607915133430 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Ligation clip, metallic
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