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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: CA090, DIRECT DRIVE® LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTS22, 12x100 Kii® SLEEVE ZTHR 12/BX CTB73, 12x100 Kii® SH BLD ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0694
In Commercial Distribution

  • 30607915123803 ()


  • 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 CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTB73, 12x100 Kii® SH BLD ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0693
In Commercial Distribution

  • 30607915123797 ()


  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: B3827, SIL MUL-LGTH COMFORT 4.6Fx22-30CM B8134, UROWIRE 1/BX
APPLIED MEDICAL RESOURCES CORPORATION
BS129
Not in Commercial Distribution

  • 30607915123759 ()


  • Polymeric ureteral stent
  • Gastro-urological guidewire, single-use
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0687
In Commercial Distribution

  • 30607915123674 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CA090, DIRECT DRIVE® LCA 3/BX C0R83,12x60 Kii® OPT ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
CK302
In Commercial Distribution

  • 30607915123254 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
  • Laparoscopic multi-instrument access port, single-use
  • Tissue extraction bag
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0651
In Commercial Distribution

  • 30607915123209 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0646
In Commercial Distribution

  • 30607915123155 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
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
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