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: CTR03, 5x100 Kii® OPT ZTHR 6/BX CTR73 12X100 Kii® OPT ZTHR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX C4120, 38CM GRASPER REPOS CART, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB010, 5MMx34CM SCISSOR REPOS CRTR 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2739
In Commercial Distribution

  • 30607915134373 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Kit Contains: CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX C4120, 38CM GRASPER REPOS CART, 10/BX CB010, 5MMx34CM SCISSOR REPOS CRTR 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2736
In Commercial Distribution

  • 30607915134366 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Rigid endoscopic grasping forceps, single-use
  • 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 C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFB03, 5x100 Kii® SH BLD ADVFIX, 6/BX CB010, 5MMx34CM SCISSOR REPOS CRTR 10/BX C4120, 38CM GRASPER REPOS CART, 10/BX CTB73, 12x100 Kii® SH BLD ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2738
In Commercial Distribution

  • 30607915134359 ()


  • Rigid endoscopic grasping forceps, single-use
  • 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 CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFB03, 5x100 Kii® SH BLD ADVFIX, 6/BX CFB73, 12x100 Kii® SH BLD ADVFIX 6/BX C4120, 38CM GRASPER REPOS CART, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2735
In Commercial Distribution

  • 30607915134342 ()


  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX CA090, DIRECT DRIVE® LCA 3/BX CFF33, 11X100 Kii® Fios® ADVFIX 6/BX CY010, 5mmX35cm EPIX® LAPA DISSECT, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2716
In Commercial Distribution

  • 30607915134304 ()


  • Laparoscopic electrosurgical blunt dissector
  • Spring-loaded pneumoperitoneum needle, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTF73, 12x100 Kii® Fios® ZTHR 6/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX C4119, 32CM GRASPER REPOS CART, 10/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2681
In Commercial Distribution

  • 30607915133970 ()


  • Rigid endoscopic grasping forceps, single-use
  • Laparoscopic access cannula, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
BellaVisage Hybrid
In Commercial Distribution

  • 17290112452013 ()
  • 07290112452016 ()
7290112452016

  • Radio-frequency skin surface treatment system
The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
Titan AllWays
In Commercial Distribution

  • 17290112451559 ()
  • 07290112451552 ()
7290112451552

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
BellaVisage
In Commercial Distribution

  • 17290112450224 ()
  • 07290112450227 ()
  • 27290112450221 ()
7290112450227

  • Radio-frequency skin surface treatment system
Fractora 24P
INMODE M.D LTD
AG602426A
In Commercial Distribution

  • 17290016633150 ()
  • 07290016633153 ()
AG602426A

  • Radio-frequency skin surface treatment system
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