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 prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 5.9 H 3 mm for internal hex connection
In Commercial Distribution

  • 08051511801442 ()

  • Height: 3 Millimeter
  • Outer Diameter: 5.9 Millimeter
VG592

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 5.2 H 5 mm for internal hex connection
In Commercial Distribution

  • 08051511801435 ()

  • Height: 5 Millimeter
  • Outer Diameter: 5.2 Millimeter
VG524

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 5.2 H 3 mm for internal hex connection
In Commercial Distribution

  • 08051511801428 ()

  • Height: 3 Millimeter
  • Outer Diameter: 5.2 Millimeter
VG522

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 4.5 H 5 mm for internal hex connection
In Commercial Distribution

  • 08051511801411 ()

  • Height: 5 Millimeter
  • Outer Diameter: 4.5 Millimeter
VG454

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 4.5 H 3 mm for internal hex connection
In Commercial Distribution

  • 08051511801404 ()

  • Height: 3 Millimeter
  • Outer Diameter: 4.5 Millimeter
VG452

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 3.8 H 5 mm for internal hex connection
In Commercial Distribution

  • 08051511801398 ()

  • Outer Diameter: 3.8 Millimeter
  • Height: 5 Millimeter
VG384

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 3.8 H 3 mm for internal hex connection
In Commercial Distribution

  • 08051511801381 ()

  • Height: 3 Millimeter
  • Outer Diameter: 3.8 Millimeter
VG382

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 3.3 H 5 mm for internal hex connection
In Commercial Distribution

  • 08051511801374 ()

  • Height: 5 Millimeter
  • Outer Diameter: 3.3 Millimeter
VG334

  • Dental implant system
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Healing screws are used to cover the fixtures and to model the mucosa during her healing.
BIOSAF IN SRL
counterbore healing screw Ø 3.3 H 3 mm for internal hex connection
In Commercial Distribution

  • 08051511801367 ()

  • Outer Diameter: 3.3 Millimeter
  • Height: 3 Millimeter
VG332

  • Dental implant system
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112114SND
In Commercial Distribution

  • 10381780047469 ()
  • M248112114SND1 ()

  • 2.7mm diam. x 14mm length
112114SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112113SND
In Commercial Distribution

  • 10381780047445 ()
  • M248112113SND1 ()

  • 2.7mm diam. x 13mm length
112113SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112112SND
In Commercial Distribution

  • 10381780047421 ()
  • M248112112SND1 ()

  • 2.7mm diam. x 12mm length
112112SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112111SND
In Commercial Distribution

  • 10381780047407 ()
  • M248112111SND1 ()

  • 2.7mm diam. x 11mm length
112111SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112014SND
In Commercial Distribution

  • 10381780047384 ()
  • M248112014SND1 ()

  • 2mm diam. x 14mm length
112014SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112013SND
In Commercial Distribution

  • 10381780047360 ()
  • M248112013SND1 ()

  • 2mm diam. x 13mm length
112013SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112012SND
In Commercial Distribution

  • 10381780047346 ()
  • M248112012SND1 ()

  • 2mm diam. x 12mm length
112012SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, her head is blocked and the breaking torque is enough important to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered sterile.
NEWDEAL
112011SND
In Commercial Distribution

  • 10381780047322 ()
  • M248112011SND1 ()

  • 2mm diam. x 11mm length
112011SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication. and storage. RamSoft PACS is tested according to the specifications that are documented in a RamSoft PACS System Test Plan. Testing is an integral part of RamSoft's software development process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSPACS6PRU11B0 ()
PSPACS6PRU11B

  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 XS
In Commercial Distribution

  • 05391512285791 ()
  • 05391512281458 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 4XL
In Commercial Distribution

  • 05391512285869 ()
  • 05391512281120 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 3XL
In Commercial Distribution

  • 05391512285852 ()
  • 05391512281113 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 XXL
In Commercial Distribution

  • 05391512281106 ()
  • 05391512285845 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 XL
In Commercial Distribution

  • 05391512285838 ()
  • 05391512281090 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 L
In Commercial Distribution

  • 05391512285821 ()
  • 05391512281083 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 M
In Commercial Distribution

  • 05391512285814 ()
  • 05391512281076 ()
584

  • Lumbar spine orthosis
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. The M-Spine consists of 3 separate pieces: A back brace corset fitted with eight (8) flexible steel stays, a covered lumbar thermoplastic panel and an abdominal thermoplastic panel.
INDACO SRL
584 S
In Commercial Distribution

  • 05391512285807 ()
  • 05391512281069 ()
584

  • Lumbar spine orthosis
Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following: + Health behaviors (e.g., smoking and exercise); + Screening tests (e.g., blood cholesterol and mammography); + Health history among his or her first- and second-degree relatives. One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages. The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders.
SANITAS, INC.
Version 2.0 Released 20160615
Not in Commercial Distribution

  • 00860508000304 ()


  • Self-care monitoring/reporting software
The Spiro PD personal spirometer is a hand held device that is used to test the user’s lung capacity. Measures of air flow and volume are indicators of lung health. By blowing into the tube of the Spiro PD the user can see a measure of his/her forced expiratory volume for one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF), and forced expiratory flow from 25% to 75% (FEF 25/75). The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is intended to be used as a single-patient device only and can be used in any setting - home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: • 2-12 years - Child • 13-21 years - Adolescent • 22 and over- Adult.
PMD HEALTHCARE, INC.
1.0
In Commercial Distribution

  • 00857845006007 ()
10000101

  • Diagnostic spirometer, professional
THINNER, SOLVENT, ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, LATEX-FREE, NON-FLAMMABLE The use of Uro-Bond® Thinner may be deemed necessary where Uro-Bond® V Brush-on Silicone Adhesives have thickened (this sometimes occurs when the bottles are opened frequently as the solvents used are highly evaporative in nature). Suggested uses include but are not limited to use as a dilutant for Uro-Bond® V Brush-on Silicone Adhesive as well as a degreasing agent or a solvent. However, Urocare® does not recommend the use of Uro-Bond® Thinner as an adhesive remover—we recommend using an alternative product for that purpose—see Urocare® Adhesive Remover Pads #5600. 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.
501503
In Commercial Distribution

  • 00792293501530 ()
  • 10792293501537 ()

  • Width: 2.38 Inch
  • Length: 2.38 Inch
  • Height: 4.38 Inch
  • Total Volume: 88.7 Milliliter
  • Total Volume: 3 Fluid Ounce
  • Weight: 0.55 Pound
501503

  • Urinary incontinence penis sheath/port, single-use
  • Skin surface device adhesive
THINNER, SOLVENT, ADHESIVE, SILICONE, URINE COLLECTION, OSTOMY, LATEX-FREE, FLAMMABLE The use of Uro-Bond® Thinner may be deemed necessary where Uro-Bond® III Brush-on Silicone Adhesives have thickened (this sometimes occurs when the bottles are opened frequently as the solvents used are highly evaporative in nature). Suggested uses include but are not limited to use as a dilutant for Uro-Bond® III Brush-on Silicone Adhesive as well as a degreasing agent or a solvent. However, Urocare® does not recommend the use of Uro-Bond® Thinner as an adhesive remover—we recommend using an alternative product for that purpose—see Urocare® Adhesive Remover Pads #5600. NOTE: Since the actual use of Uro-Bond® Thinner or products otherwise incorporating Uro-Bond® Thinner 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. FLAMMABLE
UROCARE PRODUCTS, INC.
501003
In Commercial Distribution

  • 00792293501035 ()
  • 10792293501032 ()

  • Weight: 0.44 Pound
  • Total Volume: 3 Fluid Ounce
  • Total Volume: 88.7 Milliliter
  • Height: 3.56 Inch
  • Length: 2.0 Inch
  • Width: 2.0 Inch
501003

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