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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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Auto Tono/Refracto/Kerato/Pachymeter HTR-1A - 08800019600558

Auto Tono/Refracto/Kerato/Pachymeter HTR-1A
Huvitz Co., Ltd.
HTR-1A
In Commercial Distribution

  • 08800019600558 ()
HTR-1A

  • Ophthalmic tonometer, battery-operated
  • Automated ophthalmic refractometer
  • Bench-top keratometer

AUTO REF/KERATO/TONOMETER - 04987669100066

AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye.
NIDEK CO.,LTD.
TONOREF II
In Commercial Distribution

  • 04987669100066 ()


  • Ophthalmic tonometer, line-powered
  • Bench-top keratometer
  • Automated ophthalmic refractometer

Uro-Kit® Reusable Latex Leg Bag System 44 oz. - 00792293995445

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, EXTRA-LARGE, 44 FL. OZ. (1,300 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9544, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
99544
In Commercial Distribution

  • 00792293995445 ()

  • Total Volume: 1300 Milliliter
  • Total Volume: 44 Fluid Ounce
  • Height: 6.75 Inch
  • Width: 6.00 Inch
  • Depth: 10 Inch
  • Weight: 1.90 Pound
99544

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

Uro-Kit® Reusable Latex Leg Bag System 32 oz. - 00792293995322

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LARGE, 32 FL. OZ. (1,000 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9532, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
99532
In Commercial Distribution

  • 00792293995322 ()

  • Total Volume: 32 Fluid Ounce
  • Total Volume: 1000 Milliliter
  • Height: 6.75 Inch
  • Width: 6.0 Inch
  • Depth: 10.0 Inch
  • Weight: 1.82 Pound
99532

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

Uro-Kit® Reusable Latex Leg Bag System 32 oz. - 00792293985323

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LARGE-OVAL, 32 FL. OZ. (1,000 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8532, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
98532
In Commercial Distribution

  • 00792293985323 ()

  • Depth: 10.0 Inch
  • Width: 6.0 Inch
  • Weight: 1.84 Pound
  • Height: 6.75 Inch
  • Total Volume: 1000 Milliliter
  • Total Volume: 32 Fluid Ounce
98532

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

Uro-Kit® Reusable Latex Leg Bag System 18 oz. - 00792293985187

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, MEDIUM, 18 FL. OZ. (550 ML.) CONTENTS: 1 Reusable Latex Urinary Leg Bag #8518, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
98518
In Commercial Distribution

  • 00792293985187 ()

  • Depth: 10.0 Inch
  • Width: 6.0 Inch
  • Weight: 1.78 Pound
  • Height: 6.75 Inch
  • Total Volume: 550 Milliliter
  • Total Volume: 18 Fluid Ounce
98518

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

Uro-Kit® Reusable Latex Leg Bag System 26 oz. - 00792293995261

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LONG-SLIM, 26 FL. OZ. (800 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9526, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
99526
In Commercial Distribution

  • 00792293995261 ()

  • Height: 6.75 Inch
  • Width: 6 Inch
  • Depth: 10.0 Inch
  • Total Volume: 800 Milliliter
  • Total Volume: 26 Fluid Ounce
  • Weight: 1.86 Pound
99526

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

Uro-Kit® Reusable Latex Leg Bag System 26 oz. - 00792293985262

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SHORT-WIDE, 26 FL. OZ. (800 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8526, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
98526
In Commercial Distribution

  • 00792293985262 ()

  • Total Volume: 26 Fluid Ounce
  • Total Volume: 800 Milliliter
  • Height: 6.75 Inch
  • Weight: 1.78 Pound
  • Width: 6.0 Inch
  • Depth: 10.0 Inch
98526

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

Uro-Kit® Reusable Latex Leg Bag System 9 oz. - 00792293985095

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SMALL, 9 FL. OZ. (270 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #8509, 1 Upper Fabric Leg Strap #6344, 1 Bottle of Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
98509
In Commercial Distribution

  • 00792293985095 ()

  • Total Volume: 9 Fluid Ounce
  • Total Volume: 270 Milliliter
  • Height: 6.75 Inch
  • Weight: 1.70 Pound
  • Width: 6.0 Inch
  • Depth: 10.0 Inch
98509

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

Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.) - 00792293995162

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT LARGE, 16 FL. OZ. (500 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9516, 1 Fabric Sport Bag Strap #6342, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
UROCARE PRODUCTS, INC.
99516
In Commercial Distribution

  • 00792293995162 ()

  • Total Volume: 16 Fluid Ounce
  • Total Volume: 500 Milliliter
  • Depth: 10.0 Inch
  • Height: 6.75 Inch
  • Width: 6.0 Inch
  • Weight: 1.78 Pound
99516

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