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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Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B7076, FORTE AxP SET 12/14/18F 28CM 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
BK025
Not in Commercial Distribution

  • 20607915128207 ()


  • Ureteral stent-placement set
  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3301, STENT, C-FLEX, 7/10F X 26CM B7076, FORTE AxP SET 12/14/18F 28CM 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
BK024
Not in Commercial Distribution

  • 20607915128191 ()


  • Ureteral stent-placement set
  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B7076, FORTE AxP SET 12/14/18F 28CM 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
BK023
Not in Commercial Distribution

  • 20607915128184 ()


  • Ureteral stent-placement set
  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3305, STENT, C-FLEX 7/10F x 22 CM
APPLIED MEDICAL RESOURCES CORPORATION
BK022
Not in Commercial Distribution

  • 20607915128177 ()


  • Ureteral stent-placement set
  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3306, STENT, C-FLEX 7/10F x 20 CM
APPLIED MEDICAL RESOURCES CORPORATION
BK021
Not in Commercial Distribution

  • 20607915128160 ()


  • Ureteral stent-placement set
  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
Kit Contains: C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CFF73, 12x100 Kii Fios ADVFIX 6/BX CFF03, 5x100 Kii Fios ADVFIX 6/BX CFF33, 11X100 Kii Fios ADVFIX 6/BX CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CA090, DIRECT DRIVE LCA 3/BX C8702, M ALEXIS LAP SYS W/Kii Fios 5/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK253
In Commercial Distribution

  • 20607915133898 ()


  • General surgical procedure kit, non-medicated, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic electrosurgical blunt dissector
  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Ligation clip, metallic
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