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 CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX C0R37, Kii® 15X100mm Z-THR OPT SYS, 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2439
In Commercial Distribution

  • 30607915131860 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTF73, 12x100 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
APPLIED MEDICAL RESOURCES CORPORATION
K2438
In Commercial Distribution

  • 30607915131853 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM
APPLIED MEDICAL RESOURCES CORPORATION
CK406
In Commercial Distribution

  • 30607915131846 ()


  • Laparoscopic multi-instrument access port, single-use
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2461
In Commercial Distribution

  • 30607915131839 ()


  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2452
In Commercial Distribution

  • 30607915131761 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2402
In Commercial Distribution

  • 30607915131723 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2445
In Commercial Distribution

  • 30607915131600 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2426
In Commercial Distribution

  • 30607915131594 ()


  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2444
In Commercial Distribution

  • 30607915131570 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
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
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