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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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Amplichek II Level 1 (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000202
In Commercial Distribution

  • 00847661005933 ()
12000202

  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
Amplichek II Negative (A nucleic acid control.)
BIO-RAD LABORATORIES, INC.
12000201
In Commercial Distribution

  • 00847661005926 ()
12000201

  • Clostridium difficile nucleic acid IVD, control
  • MRSA nucleic acid IVD, control
  • Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, EXTRA-LARGE Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Extra-Large #4423, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
94404
In Commercial Distribution

  • 00792293944047 ()

  • Weight: 1.04 Pound
  • Length: 9.00 Inch
  • Width: 6.25 Inch
  • Height: 4.00 Inch
  • Total Volume: 1000 Milliliter
  • Circumference: 40 Millimeter
  • Total Volume: 32 Fluid Ounce
  • Lumen/Inner Diameter: 20 Millimeter
94404

  • Penis/scrotum wearable urinal
  • Open-ended wearable urine collection bag, non-sterile
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGE Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
94403
In Commercial Distribution

  • 00792293944030 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Total Volume: 32 Fluid Ounce
  • Circumference: 40 Millimeter
  • Total Volume: 1000 Milliliter
  • Height: 4.00 Inch
  • Width: 6.25 Inch
  • Length: 9.00 Inch
  • Weight: 1.04 Pound
94403

  • Open-ended wearable urine collection bag, non-sterile
  • Penis/scrotum wearable urinal
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, LARGE Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Large #4421, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
94401
In Commercial Distribution

  • 00792293944016 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Total Volume: 32 Fluid Ounce
  • Circumference: 40 Millimeter
  • Total Volume: 1000 Milliliter
  • Height: 4.00 Inch
  • Width: 6.25 Inch
  • Length: 9.00 Inch
  • Weight: 1.04 Pound
94401

  • Open-ended wearable urine collection bag, non-sterile
  • Penis/scrotum wearable urinal
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUM Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Small #4420, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
94400
In Commercial Distribution

  • 00792293944009 ()

  • Weight: 1.04 Pound
  • Length: 9.00 Inch
  • Width: 6.25 Inch
  • Height: 4.00 Inch
  • Total Volume: 1000 Milliliter
  • Circumference: 40 Millimeter
  • Total Volume: 32 Fluid Ounce
  • Lumen/Inner Diameter: 20 Millimeter
94400

  • Penis/scrotum wearable urinal
  • Open-ended wearable urine collection bag, non-sterile
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, SMALL Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Small #4420, 1 Male Urinal Sheath Small #4409, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
94399
In Commercial Distribution

  • 00792293943996 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Total Volume: 32 Fluid Ounce
  • Circumference: 40 Millimeter
  • Total Volume: 1000 Milliliter
  • Height: 4.00 Inch
  • Width: 6.25 Inch
  • Length: 9.00 Inch
  • Weight: 1.04 Pound
94399

  • Open-ended wearable urine collection bag, non-sterile
  • Penis/scrotum wearable urinal
BRUSH, CLEANING, APPLIANCE, URINARY, OSTOMY, SMALL PARTS, STAINLESS STEEL, NYLON BRISTLES, 8" (20CM) This brush is made with durable, white-nylon bristles and a malleable, twisted, stainless-steel wire body. It may be shaped to fit almost any contour and is especially good for removing uric crystal build-ups from within urinary and ostomy appliances. May be used with Urocare® reusable Latex urinary leg bags, Urocare® Urinary Drainage Bottle, Urocare® Male Urinal Systems, Urocare® Male Urinal Kits or any other urinary or ostomy appliance that has small parts, tight corners, small holes and other hard to reach areas that need periodic brushing to loosen calcium and uric crystal build-ups. Rinsing alone does not clean a urinary or ostomy appliance and the use of vinegar, bleaches or toilet bowl cleaners only hardens, distorts and damages rubber, latex and plastic parts—not to mention the unpleasant and embarrassing odors often created by the use of these chemicals. Urocare® recommends the use of Urolux® urinary and ostomy appliance cleanser and deodorant for cleaning latex or rubber urinary leg bags, male urinal sheaths, urinary drainage bottles, urinary drainage and extension tubing or any other reusable urinary or ostomy appliance. Urolux® is a concentrated solution specifically formulated to clean and deodorize rubber, latex or plastic urinary and ostomy appliances. Crystal build-ups are dissolved and unpleasant odors are eliminated. Don't let corrosion happen to your urinary or ostomy appliance... Use Urolux!
UROCARE PRODUCTS, INC.
7003
In Commercial Distribution

  • 10792293070033 ()
  • 00792293070036 ()

  • Bristles: 0.25" O.D. x 0.75" O.D. x 3.38" Bristles: (0.6cm Ø x 1.9cm Ø x 8.6cm)
  • Length: 20 Centimeter
  • Outer Diameter: 1.9 Centimeter
  • Length: 8.00 Inch
  • Outer Diameter: 0.75 Inch
  • Weight: 0.40 Pound
7003

  • Endoscope cleaning brush, reusable
  • Penis/scrotum wearable urinal
  • Non-wearable adult urine collection bag, open-ended
  • Open-ended wearable urine collection bag, non-sterile
  • Hand-held urinal, reusable
  • Urinary incontinence penis sheath/port, single-use
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MN050
In Commercial Distribution

  • 00857570006167 ()

  • Weight: 0.5 Gram


  • Endodontic filling/sealing material
  • Dental pulp-capping material
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
MN200
In Commercial Distribution

  • 00857570006150 ()

  • Weight: 2.0 Gram


  • Dental pulp-capping material
  • Endodontic filling/sealing material
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