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 double tier MicroTray Sterilization Tray.
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM2551-2-CS
In Commercial Distribution

  • 00844735005875 ()
519321006011

  • Vascular anastomosis coupling kit, reusable
Pep Electrode Kit™
RHYTHMLINK INTERNATIONAL, LLC
RLSP370
In Commercial Distribution

  • 00816312022520 ()


  • Subdermal needle electrode
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
Kit Contains: CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2422
In Commercial Distribution

  • 30607915131501 ()


  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • 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 CTS02, 5x100 Kii® SLEEVE ZTHR 12/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
K2431
In Commercial Distribution

  • 30607915131471 ()


  • 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 CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2334
In Commercial Distribution

  • 30607915131464 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® 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
K2427
In Commercial Distribution

  • 30607915131419 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C0R95, 12x100 Kii® BLUNT TIP SM CONE 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2400
In Commercial Distribution

  • 30607915131266 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
  • Laparoscopic access cannula, single-use
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 C0R95, 12x100 Kii® BLUNT TIP SM CONE 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2401
In Commercial Distribution

  • 30607915131259 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE® LCA 3/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX CTR12, 5x100 Kii® OPT ZTHR DP 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2399
In Commercial Distribution

  • 30607915131082 ()


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