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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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STRAP, FABRIC, LOWER, LEG BAG, LATEX-FREE, VELCRO FASTENERS, SMALL, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9544, #9532, #9526, #8532, #8526 and #8518. 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 strap loops of the 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 STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6348
In Commercial Distribution

  • 10792293063486 ()
  • 00792293063489 ()

  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
  • 2" (5cm) Wide, Fits: 7" ~ 13" DIA. (18cm x 33cm Ø)
  • Weight: 0.04 Pound
6348

  • Open-ended wearable urine collection bag, non-sterile
STRAP, FABRIC, LOWER, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9544, #9532, #9526, #8532, #8526 and #8518. 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 strap loops of the 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 STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6345
In Commercial Distribution

  • 10792293063455 ()
  • 00792293063458 ()

  • Weight: 0.04 Pound
  • 2"(5cm) Wide, Fits: 12" ~ 17" DIA. (31cm x 43cm Ø)
  • Can hold up to a 32 fl. oz. (1,000 mL.) leg bag
6345

  • Open-ended wearable urine collection bag, non-sterile
STRAP, FABRIC, SPORT, LEG BAG, LATEX-FREE, VELCRO FASTENERS, MEDIUM, LARGE, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9516, #9510, #8516 and #8510. 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 strap loops of the 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 STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6343
In Commercial Distribution

  • 00792293063434 ()
  • 10792293063431 ()

  • Weight: 0.04 Pound
  • 2" (5cm) Wide, Fits: 19" ~ 30" DIA. (48cm x 76cm Ø)
  • Can hold up to a 16 fl. oz. (500 mL.) leg bag
6343

  • Open-ended wearable urine collection bag, non-sterile
STRAP, FABRIC, SPORT, LEG BAG, LATEX-FREE, VELCRO FASTENERS, SMALL, MEDIUM, REUSABLE For use with Urocare® reusable latex urinary leg bags: #9516, #9510, #8516 and #8510. 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 strap loops of the 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 STRAP LOOPS FOR STRAP TIES TO PASS THROUGH
UROCARE PRODUCTS, INC.
6342
In Commercial Distribution

  • 10792293063424 ()
  • 00792293063427 ()

  • Can hold up to a 16 fl. oz. (500 mL.) leg bag
  • 2" (5cm) Wide, Fits: 14" ~ 24" DIA. (36cm x 61cm Ø)
  • Weight: 0.04 Pound
6342

  • Open-ended wearable urine collection bag, non-sterile
Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions.
FAXITRON BIOPTICS, LLC
VisionCT 15x15
In Commercial Distribution

  • 00857069006227 ()


  • Stationary specimen x-ray system, digital
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
Best Nomos
015-A237
In Commercial Distribution

  • 00852656007465 ()


  • Prostate biopsy needle
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
Best Nomos
015-A237
In Commercial Distribution

  • 00852656007458 ()


  • Prostate biopsy needle
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
Best Nomos
015-A200
In Commercial Distribution

  • 00852656007434 ()


  • Prostate biopsy needle
The Niagara Sonic Irrigatior PCF Washer Disinfector has a built in ultrasonic chamber for Sonic Irrigation cleaning of 48 lumen OR 20 da Vinci instruments.
MEDISAFE UK LIMITED
Niagara Sonic Irrigator PCF
Not in Commercial Distribution

  • 05060247262031 ()
MED1406

  • Surgical utensil washer/disinfector
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