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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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Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM
APPLIED MEDICAL RESOURCES CORPORATION
BK016
Not in Commercial Distribution

  • 30607915123056 ()


  • Polymeric ureteral stent
  • Ureteral catheter
  • Gastro-urological guidewire, single-use
Kit Contains: CTR33, 11X100 Kii® OPT ZTHR 6/BX CTR12, 5x100 Kii® OPT ZTHR DP 10/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0640
In Commercial Distribution

  • 30607915122981 ()


  • Ligation clip, metallic
  • Laparoscopic access cannula, single-use
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2155
In Commercial Distribution

  • 30607915122226 ()


  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2154
In Commercial Distribution

  • 30607915122219 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
  • Tissue extraction bag
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2150
In Commercial Distribution

  • 30607915122189 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTR12, 5x100 Kii® OPT ZTHR DP 10/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2136
In Commercial Distribution

  • 30607915122172 ()


  • 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 CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0522
In Commercial Distribution

  • 30607915121946 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB010, 5MMx34CM SCISSOR REPOS CRTR 10/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0509
In Commercial Distribution

  • 30607915121885 ()


  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0491
In Commercial Distribution

  • 30607915121793 ()


  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
Kit Contains: CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0477
In Commercial Distribution

  • 30607915121731 ()


  • Ligation clip, metallic
  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
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