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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Phasix ST Mesh with Open Positioning System, 8 cm x 12 cm (3" x 5"), Oval
Davol Inc.
1220812
In Commercial Distribution

  • 00801741163197 ()

  • Width: 12 Centimeter
  • Length: 8 Centimeter
1220812

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Phasix ST Mesh with Open Positioning System, 11 cm (4.5"), Circle
Davol Inc.
1220011
In Commercial Distribution

  • 00801741163173 ()

  • Outer Diameter: 11 Centimeter
1220011

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Kit Contains: CTB73, 12x100 Kii® SH BLD ZTHR 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTB12, 5x100 Kii® SH BLD ZTHR DP 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2369
In Commercial Distribution

  • 30607915130429 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFB12, 5x100 Kii® SH BLD ADVFIX DP 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2371
In Commercial Distribution

  • 30607915130252 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2321
In Commercial Distribution

  • 30607915129942 ()


  • Laparoscopic access cannula, single-use
  • Rigid endoscopic grasping forceps, single-use
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
CK391
In Commercial Distribution

  • 30607915129829 ()


  • Tissue extraction bag
  • Laparoscopic multi-instrument access port, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2347
In Commercial Distribution

  • 30607915129799 ()


  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2345
In Commercial Distribution

  • 30607915129768 ()


  • Spring-loaded pneumoperitoneum needle, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2336
In Commercial Distribution

  • 30607915129683 ()


  • 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 C2201, 120MM INSUFF NEEDLE XE, 20/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CFF12, 5x100 Kii® Fios® ADVFIX DP 10/BX CFF33, 11X100 Kii® Fios® ADVFIX 6/BX CFS12, 11x100 Kii® SLEEVE ADVFIX 12/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2332
In Commercial Distribution

  • 30607915129669 ()


  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Spring-loaded pneumoperitoneum needle, single-use
  • Ligation clip, metallic
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