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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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The P.T.Rail is a high quality, commercial grade, fold down rail for use beside a toilet. The P.T.Rail features an offset handle to help reduce strain when gripping the lower rail. The P.T.Rail is intended for moderate vertical and horizontal load bearing to provide sitting and standing toilet support for people with reduced mobility. The P.T.Rail is intended to bear weight ONLY when the handle is in the down position; the handle is not intended to bear weight in any other position. The P.T.Rail handle is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The P.T.Rail is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight. The P.T.Rail is not to be used in any other way than described above.
Healthcraft Products Inc.
PT-ANG32-PCW
In Commercial Distribution

  • 00689281011990 ()
01199

  • Toilet hand rail
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.006.0800
In Commercial Distribution

  • EKAV100608000 ()
E675 LMW

  • Dental power tool system handpiece, pneumatic
The Invisia Soap Dish is a combination grab bar and soap dish, designed to disguise safety in a bathroom accessory. The Invisia Soap Dish is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Soap Dish is installed with appropriate fasteners to a structural wall. The soap tray (which holds soap) is removable for cleaning and is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight
Healthcraft Products Inc.
INV-SD-ORB
In Commercial Distribution

  • 00689281033428 ()
03342

  • Bath hand rail
The Invisia Soap Dish is a combination grab bar and soap dish, designed to disguise safety in a bathroom accessory. The Invisia Soap Dish is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Soap Dish is installed with appropriate fasteners to a structural wall. The soap tray (which holds soap) is removable for cleaning and is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight
Healthcraft Products Inc.
INV-SD-CP
In Commercial Distribution

  • 10689281033418 ()
  • 00689281033411 ()
03341

  • Bath hand rail
The Invisia Soap Dish is a combination grab bar and soap dish, designed to disguise safety in a bathroom accessory. The Invisia Soap Dish is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Soap Dish is installed with appropriate fasteners to a structural wall. The soap tray (which holds soap) is removable for cleaning and is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight
Healthcraft Products Inc.
INV-SD-BS
In Commercial Distribution

  • 10689281033401 ()
  • 00689281033404 ()
03340

  • Bath hand rail
The SuperPole FRS is a high quality, commercial grade support receptacle that is permanently embedded into a structural concrete floor to be used exclusively with the SuperPole FRS-Pole. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight. The SuperPole F.R.S. is not to be used in any other way than described
Healthcraft Products Inc.
FRS-FR
In Commercial Distribution

  • 00689281005050 ()
00505

  • Fixed-rail armrest
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Extra Large
HIDRAMED SOLUTIONS LIMITED
GBB001-04
In Commercial Distribution

  • 05391535510313 ()


  • Non-adhesive device retention bandage
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Large
HIDRAMED SOLUTIONS LIMITED
GBB001-03
In Commercial Distribution

  • 05391535510306 ()


  • Non-adhesive device retention bandage
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Medium
HIDRAMED SOLUTIONS LIMITED
GBB001-02
In Commercial Distribution

  • 05391535510290 ()


  • Non-adhesive device retention bandage
The HidraWear BB Women’s Briefs device is a garment device, which is intended for the retention of a dressing in the buttocks and groin area. The HidraMed BB Women’s Briefs is a garment device designed to remove the requirement to attach the dressing to the skin. The garment is worn underneath or in place of regular underwear and then a dressing is applied to the buttocks and groin area. A fastening mechanism such as tape is used to attach the dressing to the garment. The device is intended to be used by a home user that requires routine wound care. Size: Small
HIDRAMED SOLUTIONS LIMITED
GBB001-01
In Commercial Distribution

  • 05391535510283 ()


  • Non-adhesive device retention bandage
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