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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The GEM MicroTray MAX System consists of a reusable Anastomotic Instrument, two reusable COUPLER Forceps, a reusable Double-Ended Vessel Measuring Gauge, two MircoClip Appliers and a single tier MicroTray Sterilization Tray.
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM2551-CS
In Commercial Distribution

  • 00844735005868 ()
519311006011

  • Vascular anastomosis coupling kit, reusable
LOANER Wormald Hemorrhage Control (Vascular Clamps) Kit
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MCEN189LP
In Commercial Distribution

  • 10381780490401 ()
MCEN189LP

  • Open-surgery ligation clip applier
  • Nasal speculum, reusable
  • Instrument tray, reusable
  • General-purpose surgical scissors, reusable
  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Pep Electrode Kit™
RHYTHMLINK INTERNATIONAL, LLC
RLSP370
In Commercial Distribution

  • 00816312022520 ()


  • Subdermal needle electrode
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFB03, 5x100 Kii® SH BLD ADVFIX, 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2849
In Commercial Distribution

  • 30607915136278 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2853
In Commercial Distribution

  • 30607915136193 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, 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 CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTB73, 12x100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2856
In Commercial Distribution

  • 30607915136186 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2855
In Commercial Distribution

  • 30607915136179 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2841
In Commercial Distribution

  • 30607915135974 ()


  • Spring-loaded pneumoperitoneum needle, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFR03, 5X100 Kii® OPT ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFR73, 12x100 Kii® OPT ADVFIX 6/BX CFS22, 12x100 Kii® SLEEVE ADVFIX 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0903
In Commercial Distribution

  • 30607915135905 ()


  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2831
In Commercial Distribution

  • 30607915135783 ()


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