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 M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible steel stays, a covered lumbar thermoplastic panel, an abdominal thermoplastic panel and two lateral panels. The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. INDICATIONS : Supports from sacrum to T-9 level. Post-op: Following stabilizing surgery, following lumbar disk surgery. The addition of lateral panels makes this brace indicated for the treatment of burst fractures. Degenerative pathologies: Osteoporosis, lumbar-sacral vertebrae complaint, protrusions, arthrosis. Muscular pathologies: Muscular contractures. Practical and easy to fit, it adapts perfectly to your body. This corset acts as a corrective measure and as a support to postural defects. Breathable and non allergenic, 100% cotton
INDACO SRL
574 XL
In Commercial Distribution

  • 05391512285661 ()
  • 05391512280840 ()
574

  • Lumbar spine orthosis
The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible steel stays, a covered lumbar thermoplastic panel, an abdominal thermoplastic panel and two lateral panels. The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. INDICATIONS : Supports from sacrum to T-9 level. Post-op: Following stabilizing surgery, following lumbar disk surgery. The addition of lateral panels makes this brace indicated for the treatment of burst fractures. Degenerative pathologies: Osteoporosis, lumbar-sacral vertebrae complaint, protrusions, arthrosis. Muscular pathologies: Muscular contractures. Practical and easy to fit, it adapts perfectly to your body. This corset acts as a corrective measure and as a support to postural defects. Breathable and non allergenic, 100% cotton
INDACO SRL
574 L
In Commercial Distribution

  • 05391512285654 ()
  • 05391512280833 ()
574

  • Lumbar spine orthosis
The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible steel stays, a covered lumbar thermoplastic panel, an abdominal thermoplastic panel and two lateral panels. The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. INDICATIONS : Supports from sacrum to T-9 level. Post-op: Following stabilizing surgery, following lumbar disk surgery. The addition of lateral panels makes this brace indicated for the treatment of burst fractures. Degenerative pathologies: Osteoporosis, lumbar-sacral vertebrae complaint, protrusions, arthrosis. Muscular pathologies: Muscular contractures. Practical and easy to fit, it adapts perfectly to your body. This corset acts as a corrective measure and as a support to postural defects. Breathable and non allergenic, 100% cotton
INDACO SRL
574 M
In Commercial Distribution

  • 05391512285647 ()
  • 05391512280826 ()
574

  • Lumbar spine orthosis
The M-Spine LSO Back Brace (#574) consists of 5 separate pieces: A corset fitted with 8 flexible steel stays, a covered lumbar thermoplastic panel, an abdominal thermoplastic panel and two lateral panels. The M-Spine lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our unique locking system featuring inter-crossed straps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. INDICATIONS : Supports from sacrum to T-9 level. Post-op: Following stabilizing surgery, following lumbar disk surgery. The addition of lateral panels makes this brace indicated for the treatment of burst fractures. Degenerative pathologies: Osteoporosis, lumbar-sacral vertebrae complaint, protrusions, arthrosis. Muscular pathologies: Muscular contractures. Practical and easy to fit, it adapts perfectly to your body. This corset acts as a corrective measure and as a support to postural defects. Breathable and non allergenic, 100% cotton
INDACO SRL
574 S
In Commercial Distribution

  • 05391512285630 ()
  • 05391512280819 ()
574

  • Lumbar spine orthosis
The ACTIVDAY NO. 502 lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization, and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our patent pending locking system featuring inter-crossed steps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. ACTIVDAY NO. 502 consists of 5 separate pieces: A corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel, 2 Side lateral panels and an abdominal thermoplastic panel. Indications: • Supports from sacrum to T-9 level. • Post-op: Following stabilizing surgery, following lumbar disk surgery. • Degenerative pathologies: Osteoporosis, lumbar sacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • Practical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects. • Breathable and non allergenic, 100% cotton. • Front panel is 6 3/4” high. • Lateral Panels Included
INDACO SRL
502 M
In Commercial Distribution

  • 05391512286101 ()
  • 05391512281762 ()
502

  • Lumbar spine orthosis
The ACTIVDAY NO. 502 lumbar-sacral orthosis is designed to support the patient at all stages of his/her recovery. The moldable panels are to be applied post-op without delay for effective immobilization, and kept in place throughout the rehabilitation phase. Later the corset, worn alone, can be adapted to provide comfortable daily support thanks to the progressive immobilization capabilities of our patent pending locking system featuring inter-crossed steps and flexible plastic-covered steel stays. Combined with our comfortable and breathable knitted cotton fabric, you get a result that speaks for itself: Perfect patient compliance. ACTIVDAY NO. 502 consists of 5 separate pieces: A corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel, 2 Side lateral panels and an abdominal thermoplastic panel. Indications: • Supports from sacrum to T-9 level. • Post-op: Following stabilizing surgery, following lumbar disk surgery. • Degenerative pathologies: Osteoporosis, lumbar sacral vertebrae complaint, protrusions, arthritis. • Muscular pathologies: Muscular contractures. • Practical and easy to fit, it adapts perfectly to your body. • This corset acts as a corrective measure and as a support to postural defects. • Breathable and non allergenic, 100% cotton. • Front panel is 6 3/4” high. • Lateral Panels Included
INDACO SRL
502 S
In Commercial Distribution

  • 05391512286095 ()
  • 05391512281755 ()
502

  • Lumbar spine orthosis
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
BioWink GmbH
1
In Commercial Distribution

  • 04260749840008 ()


  • Self-care monitoring/reporting software
ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Non-Hazmat & Non-Flammable—no special handling required. • Low Odor—Virtually odor free. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! NOTE: Since the actual use of Uro-Bond® or products otherwise incorporating Uro-Bond® by others is beyond the control of Urocare®, it is the user's responsibility to independently determine the safety, toxicity, suitability and acceptability of the product's performance in a specific application for his/her own use.
UROCARE PRODUCTS, INC.
5005015
In Commercial Distribution

  • 10792293505153 ()
  • 00792293505156 ()

  • Width: 2.0 Inch
  • Length: 2.0 Inch
  • Height: 3.56 Inch
  • Total Volume: 88.7 Milliliter
  • Total Volume: 3 Fluid Ounce
  • Weight: 0.26 Pound
5005015

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive
ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Non-Hazmat & Non-Flammable—no special handling required. • Low Odor—Virtually odor free. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! NOTE: Since the actual use of Uro-Bond® or products otherwise incorporating Uro-Bond® by others is beyond the control of Urocare®, it is the user's responsibility to independently determine the safety, toxicity, suitability and acceptability of the product's performance in a specific application for his/her own use.
UROCARE PRODUCTS, INC.
500503
In Commercial Distribution

  • 00792293505033 ()
  • 10792293505030 ()

  • Weight: 0.55 Pound
  • Total Volume: 3 Fluid Ounce
  • Total Volume: 88.7 Milliliter
  • Height: 4.38 Inch
  • Length: 2.38 Inch
  • Width: 2.38 Inch
500503

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive
ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, FLAMMABLE Uro-Bond® brush-on silicone adhesives are pressure-sensitive silicone adhesives specifically formulated for unique bonding applications and are suitable for adhering non-permanent material to the body surface. Features include the retention of adhesive qualities in the presence of moisture or perspiration, their adhesive properties are unaffected by normal temperature variations or time and they adhere to many surfaces such as: skin, metals, glass, paper, fabric, plastics, silicone, organic rubber products, etc. Possible applications for Uro-Bond® adhesives might include, but are not limited to: adhering dressings, prosthetics and metal or plastic devices to the body. Securing male external urinary catheters, adhering colostomy, ileostomy and tracheostomy devices, attaching electrodes to the skin for patient monitoring, affixing surgical dressings and pads to the skin and adhering maxillo-facial prosthetic devices. Key Features: • Silicone based—for best bio-compatibility. • Completely Transparent—Great feature for facial prosthetics, tracheostomys and toupées. • Adheres to many surfaces—including other silicones. • Water and perspiration resistant—It retains it's adhesive qualities even under water. • Brush adhesive just where you need it—No messy sprays which get adhesive everywhere! NOTE: Since the actual use of Uro-Bond® or products otherwise incorporating Uro-Bond® by others is beyond the control of Urocare®, it is the user's responsibility to independently determine the safety, toxicity, suitability and acceptability of the product's performance in a specific application for his/her own use.
UROCARE PRODUCTS, INC.
5000015
In Commercial Distribution

  • 00792293500151 ()
  • 10792293500158 ()

  • Weight: 0.26 Pound
  • Total Volume: 1.5 Fluid Ounce
  • Total Volume: 44.4 Milliliter
  • Height: 2.88 Inch
  • Length: 1.6 Inch
  • Width: 1.6 Inch
5000015

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive
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