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 Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility. The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WSBB-30-HNY-BLK
In Commercial Distribution

  • 00689281034074 ()
03407

  • Bath board
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat 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 Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS26-HNY-BLK
In Commercial Distribution

  • 00689281034005 ()
03400

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat 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 Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS18-HNY-BLK
In Commercial Distribution

  • 00689281033930 ()
03393

  • Shower seat, non-powered
The Invisia Shower Bench is a high quality, commercial grade shower seat. The Invisia Shower Bench is intended to provide shower seating support for people with reduced mobility. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the bench).
Healthcraft Products Inc.
INV-WSSB-24-WNT-BLK
In Commercial Distribution

  • 00689281033787 ()
03378

  • Shower seat, non-powered
The Invisia Shower Bench is a high quality, commercial grade shower seat. The Invisia Shower Bench is intended to provide shower seating support for people with reduced mobility. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the bench).
Healthcraft Products Inc.
INV-WSSB-24-ASH-BLK
In Commercial Distribution

  • 00689281033732 ()
03373

  • Shower seat, non-powered
The Invisia Linear Bar is a curved grab bar designed to disguise safety in a bathroom accessory. The Invisia Linear Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Linear Bar is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-LB18-BLK
In Commercial Distribution

  • 00689281031776 ()
03177

  • Hand rail
The Invisia Linear Bar is a curved grab bar designed to disguise safety in a bathroom accessory. The Invisia Linear Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Linear Bar is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-LB12-BLK
In Commercial Distribution

  • 00689281031769 ()
03176

  • Bath hand rail
The Invisia Corner Seat is a high quality, commercial grade shower seat. The Invisia Corner Seat is intended to provide shower seating support for people with reduced mobility. The Invisia Corner Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WSCS-WNT-BLK
In Commercial Distribution

  • 00689281031752 ()
03175

  • Shower seat, non-powered
The Invisia Corner Seat is a high quality, commercial grade shower seat. The Invisia Corner Seat is intended to provide shower seating support for people with reduced mobility. The Invisia Corner Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WSCS-ASH-BLK
In Commercial Distribution

  • 00689281031745 ()
03174

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat 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 Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS26-ASH-BLK
In Commercial Distribution

  • 00689281031738 ()
03173

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat 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 Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS18-ASH-BLK
In Commercial Distribution

  • 00689281031721 ()
03172

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat 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 Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS26-WNT-BLK
In Commercial Distribution

  • 00689281031714 ()
03171

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat 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 Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS18-WNT-BLK
In Commercial Distribution

  • 00689281031707 ()
03170

  • Shower seat, non-powered
The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility. The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WSBB-30-ASH-BLK
In Commercial Distribution

  • 00689281031639 ()
03163

  • Bath board
The Invisia Toilet Roll Holder is a combination grab bar and toilet roll holder, designed to disguise safety in a bathroom accessory. The Invisia Toilet Roll Holder is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Toilet Roll Holder is installed with appropriate fasteners to a structural wall. The paper axle (which holds a roll of toilet paper) is product is 500lbs / 227kgs. Note: Product is not intended to support full body weight
Healthcraft Products Inc.
INV-WTRH-BLK
In Commercial Distribution

  • 10689281031612 ()
  • 00689281031615 ()
03161

  • Bath hand rail
The Invisia Corner Shelf is a combination grab bar and corner shelf, designed to disguise safety in a bathroom accessory. The Invisia Corner Shelf is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Corner Shelf is installed with appropriate fasteners to a structural wall. The tray (which holds bottles) is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs. Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-TB24-BLK
In Commercial Distribution

  • 10689281031605 ()
  • 00689281031608 ()
03160

  • Bath hand rail
The Invisia Towel Bar is a combination grab bar and towel bar, designed to disguise safety in a bathroom accessory. The Invisia Towel Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Towel Bar is installed with appropriate fasteners to a structural wall. The towel rung (which holds a towel) 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-TB16-BLK
In Commercial Distribution

  • 10689281031599 ()
  • 00689281031592 ()
03159

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

  • 10689281031582 ()
  • 00689281031585 ()
03158

  • 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. Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-SD-BLK
In Commercial Distribution

  • 00689281031578 ()
03157

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

  • 10689281031568 ()
  • 00689281031561 ()
03156

  • Bath hand rail
The Invisia Accent Ring is a circular grab bar designed to disguise safety in a bathroom accessory. The Invisia Accent Ring is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Accent Ring is to be installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-ACR-BLK
In Commercial Distribution

  • 10689281031551 ()
  • 00689281031554 ()
03155

  • Bath hand rail
The Invisia Accent Bar is a curved grab bar designed to disguise safety in a bathroom accessory. The Invisia accent Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Accent Bar is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-ACB-BLK
In Commercial Distribution

  • 10689281031544 ()
  • 00689281031547 ()
03154

  • Bath hand rail
The Invisia Linear Bar is a curved grab bar designed to disguise safety in a bathroom accessory. The Invisia Linear Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Linear Bar is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
INV-LB24-BLK
In Commercial Distribution

  • 00689281031530 ()
031530

  • Bath hand rail
The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility. The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).The Invisia Bath Bench is not to be used in any other way than described above. The Invisia Bath Bench is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the seat are made from wood (laminated bamboo).
Healthcraft Products Inc.
INV-WSBB-35-ASH-BLK
In Commercial Distribution

  • 00689281031363 ()
03136

  • Bath board
The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility. The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).The Invisia Bath Bench is not to be used in any other way than described above. The Invisia Bath Bench is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the seat are made from wood (laminated bamboo).
Healthcraft Products Inc.
INV-WSBB-35-WNT-BLK
In Commercial Distribution

  • 00689281031196 ()
03119

  • Bath board
The Invisia Bath Bench is a high quality, commercial grade bath seat. The Invisia Bath Bench is intended to provide shower seating support for people with reduced mobility. The Invisia Bath Bench rests across the top surface of the bathtub rim, and rubber feet provide friction to reduce horizontal shifting. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Invisia Bath Bench is not to be used in any other way than described above. The Invisia Bath Bench is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the seat are made from wood (laminated bamboo).
Healthcraft Products Inc.
INV-WSBB-30-WNT-BLK
In Commercial Distribution

  • 00689281031141 ()
03114

  • Bath board
The Invisia Shower Bench is a high quality, commercial grade shower seat. The Invisia Shower Bench is intended to provide shower seating support for people with reduced mobility. The maximum user weight for this product is 500lbs / 227kg
Healthcraft Products Inc.
INV-WSSB-24-MEDIUM-BLK
In Commercial Distribution

  • 00689281008266 ()
00826

  • Shower seat, non-powered
The Invisia Shower Bench is a high quality, commercial grade shower seat. The Invisia Shower Bench is intended to provide shower seating support for people with reduced mobility. The maximum user weight for this product is 500lbs / 227kgs.
Healthcraft Products Inc.
INV-WSSB-24-LIGHT-BLK
In Commercial Distribution

  • 00689281008228 ()
00822

  • Shower seat, non-powered
No Description
Laboratoires Bodycad Inc
020-130
In Commercial Distribution

  • 00688346001433 ()
020-130

  • Wire cutter
No Description
Laboratoires Bodycad Inc
027-304
In Commercial Distribution

  • 00688346000238 ()
027-304

  • Orthopaedic osteotome
No Description
Laboratoires Bodycad Inc
027-303
In Commercial Distribution

  • 00688346000221 ()
027-303

  • Orthopaedic osteotome
No Description
Laboratoires Bodycad Inc
027-301
In Commercial Distribution

  • 00688346000214 ()
027-301

  • Orthopaedic osteotome
Medicom Connections - Earloop Face Masks - Level 3 - Black
AMD Medicom Inc
208092
In Commercial Distribution

  • 00686864059127 ()
  • 00686864058144 ()
  • 00686864058151 ()
208092

  • Surgical/medical face mask, non-antimicrobial, single-use
No Description
Calyxo, Inc.
CVC127020-1
In Commercial Distribution

  • 00860005357710 ()


  • Flexible video ureteroscope, single-use
  • Intracorporeal lithotripsy suction system
Anesthesia Cart
Intermetro Industries Corporation
SXRXSANES2
Not in Commercial Distribution

  • 00860005150083 ()
SXRXSANES2

  • Anaesthetist's trolley
Anesthesia Cart
Intermetro Industries Corporation
SXRXANES2
Not in Commercial Distribution

  • 00860005150076 ()
SXRXANES2

  • Anaesthetist's trolley
Anesthesia Cart
Intermetro Industries Corporation
FLXANES1
Not in Commercial Distribution

  • 00860005150069 ()
FLXANES1

  • Anaesthetist's trolley
Anesthesia Cart
Intermetro Industries Corporation
SXRSANES2
Not in Commercial Distribution

  • 00860005150052 ()
SXRSANES2

  • Anaesthetist's trolley
Anesthesia Cart
Intermetro Industries Corporation
SXRSANES
Not in Commercial Distribution

  • 00860005150045 ()
SXRSANES

  • Anaesthetist's trolley
Sterile, Single use, Patella Fracture Repair Kit, Small
Endeavor Orthopaedics, LLC
Small
In Commercial Distribution

  • 00860004838012 ()
1316-3001

  • Orthopaedic fixation plate, non-bioabsorbable
Sterile, Single use, Patella Fracture Repair Kit, Standard
Endeavor Orthopaedics, LLC
Standard
In Commercial Distribution

  • 00860004838005 ()
1316-3000

  • Orthopaedic fixation plate, non-bioabsorbable
Vaginal applicator, single-use: A device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.
Huck Medical Technologies, Inc.
RIP-01
In Commercial Distribution

  • 00860004725107 ()
  • 00860004725121 ()
  • 00860004725114 ()

  • Shaft Length: 15 Centimeter
RIP-01

  • Vaginal applicator, single-use
Blood Pressure Cuff for the purpose of determining the subject's blood pressure. Designed for use on the wrist.
HUB EMERGENCY SERVICES, LLC
MT-WBPM-001
In Commercial Distribution

  • 00860004483915 ()


  • Blood pressure cuff, reusable
Blood Pressure Cuff for the purpose of determining the subject's blood pressure.
HUB EMERGENCY SERVICES, LLC
MT-BPM-001
In Commercial Distribution

  • 00860004483908 ()


  • Blood pressure cuff, reusable
Blood pressure monitor (TMB-1598-BS)
CURA DIGITAL HEALTH SOLUTIONS INC
TMB-1598-BS
In Commercial Distribution

  • 00860004114901 ()


  • Blood pressure cuff, reusable
No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable
Planatome Gray #15 Scalpel Blade
Planatome, LLC
GY-15
In Commercial Distribution

  • 00860011334712 ()
  • 00860003857892 ()
  • 00860011334736 ()

  • Weight: 0.413 Gram


  • Manual scalpel blade, single-use
Planatome Gray #10 Scalpel Blade
Planatome, LLC
GY-10
In Commercial Distribution

  • 00860011334705 ()
  • 00860003857885 ()
  • 00860011334729 ()


  • Manual scalpel blade, single-use
Planatome Ultra-Fine #15 Scalpel
Planatome, LLC
UF-15
In Commercial Distribution

  • 00860003857854 ()
  • 00860003857847 ()
  • 00860003857878 ()

  • Weight: .413 Gram


  • Manual scalpel blade, single-use
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