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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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PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (1.5 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
ENTOPSIS, LLC
Universal Viral Transport (100x 1.5 mL)
Not in Commercial Distribution

  • B550888100158 ()
  • B55088800015 ()
88810015

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (3 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
ENTOPSIS, LLC
Universal Viral Transport (100x 3 mL)
Not in Commercial Distribution

  • B55088800003 ()
  • B550888100038 ()
88810003

  • Viral transport medium IVD
The Kegel Toner is a powered muscle stimulator used for strengthening the pelvic floor muscles. The Kegel Toner is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.
TENSCARE LIMITED
Kegel Toner
In Commercial Distribution

  • 05033435134021 ()
K-KT

  • Perineal orifice incontinence-control electrical stimulation system
The Strike Force from Power Soccer Shop is the first wheelchair designed specifically for power soccer! Designed with a low center of gravity and wide wheelbase, the Strike Force is able to move with more agility and spin kick with more power than any other power wheelchair in the world! Equipped with top-notch components and built on a durable steel frame, this chair is ready for the rigors of elite competition.
Northern Engineering and Manufacturing, Inc.
1633
In Commercial Distribution

  • 00860008065407 ()


  • Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Zuma Implant, 38mm x 26mm x 22mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3822
Not in Commercial Distribution

  • 10889981037352 ()

  • 38mm x 26mm x 22mm, 8°
55-3822

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 20mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3820
Not in Commercial Distribution

  • 10889981037345 ()

  • 38mm x 26mm x 20mm, 8°
55-3820

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 18mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3818
In Commercial Distribution

  • 10889981037338 ()

  • 38mm x 26mm x 18mm, 8°
55-3818

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 16mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3816
In Commercial Distribution

  • 10889981037321 ()

  • 38mm x 26mm x 16mm, 8°
55-3816

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 14mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3814
In Commercial Distribution

  • 10889981037314 ()

  • 38mm x 26mm x 14mm, 8°
55-3814

  • Vertebral body prosthesis, non-sterile
Zuma Implant, 38mm x 26mm x 12mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiographic visualization; it is secured to vertebral bodies with titanium bone screws. The device has open central area(s) for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology, patient anatomy and surgical technique.
Seaspine Orthopedics Corporation
55-3812
In Commercial Distribution

  • 10889981037307 ()

  • 38mm x 26mm x 12mm, 8°
55-3812

  • Vertebral body prosthesis, non-sterile
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