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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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Mono-axial Reduction Pedicle Screw, Ø mm : 6.5, Length mm: 50 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1038-6550
In Commercial Distribution

  • 00840185306944 ()
1038-6550

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Pedicle Screw, Ø mm : 6.5, Length mm: 45 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1038-6545
In Commercial Distribution

  • 00840185306937 ()
1038-6545

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Pedicle Screw, Ø mm : 6.5, Length mm: 40 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1038-6540
In Commercial Distribution

  • 00840185306920 ()
1038-6540

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Reduction Pedicle Screw, Ø mm : 6.5, Length mm: 35 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1038-6535
In Commercial Distribution

  • 00840185306913 ()
1038-6535

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Pedicle Screw, Ø mm : 7.5, Length mm: 65 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1037-7565
In Commercial Distribution

  • 00840185306470 ()
1037-7565

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Pedicle Screw, Ø mm : 7.5, Length mm: 60 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1037-7560
In Commercial Distribution

  • 00840185306463 ()
1037-7560

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Pedicle Screw, Ø mm : 7.5, Length mm: 55 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1037-7555
In Commercial Distribution

  • 00840185306456 ()
1037-7555

  • Bone-screw internal spinal fixation system, non-sterile
STRAP, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE Fits most vinyl disposable urinary leg bags and offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6358
In Commercial Distribution

  • 00792293063588 ()

  • Weight: 0.06 Pound
  • 2" (5cm) Wide, Fits: 21" ~ 30" DIA. (53cm x 76cm Ø)
  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
6358

  • Open-ended wearable urine collection bag, non-sterile
STRAP, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE Fits most vinyl disposable urinary leg bags and offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6357
In Commercial Distribution

  • 10792293063578 ()
  • 00792293063571 ()

  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
  • 2" (5cm) Wide, Fits: 17" ~ 23" DIA. (43cm x 58cm Ø)
  • Weight: 0.04 Pound
6357

  • Open-ended wearable urine collection bag, non-sterile
STRAP, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, SMALL, REUSABLE Fits most vinyl disposable urinary leg bags and offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6356
In Commercial Distribution

  • 10792293063561 ()
  • 00792293063564 ()

  • Weight: 0.04 Pound
  • 2" (5cm) Wide, Fits: 13" ~ 20" DIA. (33cm x 50cm Ø)
  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
6356

  • Open-ended wearable urine collection bag, non-sterile
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