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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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NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.
NIDEK CO.,LTD.
EC-5000
In Commercial Distribution

  • 04987669100028 ()


  • Ophthalmic excimer laser system
NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000CXIII, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology.
NIDEK CO.,LTD.
EC-5000
In Commercial Distribution

  • 04987669100011 ()


  • Ophthalmic excimer laser system
Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(UL)
In Commercial Distribution

  • 18855036020688 ()
  • 28855036020685 ()


  • Apheresis system tubing set
Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(U)
In Commercial Distribution

  • 18855036012850 ()
  • 28855036012857 ()


  • Apheresis system tubing set
Rear Tip Extenders for AMS 700 CXR Cylinders, 2 each of Non-Stackable 4, 5, 6 cm RTEs
BOSTON SCIENTIFIC CORPORATION
72404043
In Commercial Distribution

  • 00878953002774 ()

  • Length: 6 Centimeter
  • Length: 5 Centimeter
  • Length: 4 Centimeter


  • Inflatable penile prosthesis
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
RENATA MEDICAL, INC.
FG-0002
In Commercial Distribution

  • 00196852805037 ()


  • Bare-metal aortic stent
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
RENATA MEDICAL, INC.
FG-0001
In Commercial Distribution

  • 00196852801862 ()


  • Bare-metal aortic stent
Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
SALIX PHARMACEUTICALS, LTD.
1092203
In Commercial Distribution

  • 00365649922039 ()
  • 10365649922036 ()


  • Urinary tract reconstructive material, microbe-derived
The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.
FEMCARE LIMITED
AVM-851
Not in Commercial Distribution

  • 05055515602121 ()
  • 15055515602128 ()
  • 25055515602125 ()
AVM-851

  • Fallopian tube clip/band
The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.
FEMCARE LIMITED
AVM-851J
Not in Commercial Distribution

  • 05055515602114 ()
  • 15055515602111 ()
  • 25055515602118 ()
AVM-851J

  • Fallopian tube clip/band
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