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Instrument: CC Wedge 14mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton ( opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2514T-CC
In Commercial Distribution
- 00810005669429 ()
- 14mm, Thick
- Width: 25 Millimeter
- Orthopaedic inorganic implant inserter/extractor, reusable
Instrument: CC Wedge 12mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton ( opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2512T-CC
In Commercial Distribution
- 00810005669412 ()
- 12mm, Thick
- Width: 25 Millimeter
- Orthopaedic inorganic implant inserter/extractor, reusable
Instrument: CC Wedge 10mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton ( opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2510T-CC
In Commercial Distribution
- 00810005669405 ()
- 10mm, Thick
- Width: 25 Millimeter
- Orthopaedic inorganic implant inserter/extractor, reusable
Instrument: CC Wedge 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton ( opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2508T-CC
In Commercial Distribution
- 00810005669399 ()
- 8mm, Thick
- Width: 25 Millimeter
- Orthopaedic inorganic implant inserter/extractor, reusable
BREAST 7 BIOPSY PACK, 1.5T contains - 3 Grid Immobilization Plate LBS M-L; 3 Pillar Immobilization Plate LBS M-L; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assembly; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 Grid Immobilization Plate LBS; 3 Pillar Immobilization Plate LBS C-C; 2 Fiducial Marker Sleeve Assembly; MRI Needle Sleeve 16G; Fiducial Marker Grid Block Assembly; 2 Needle Block Holder.
Philips Medical Systems Nederland B.V.
989603110736
In Commercial Distribution
- 00884838118782 ()
- Needle guide, single-use
- Needle guide, reusable
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
Steth IO
1.0
In Commercial Distribution
- 00860135001958 ()
- Electronic acoustic stethoscope
Instrument: Trigon CC Wedge Graft Packing Block. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Cotton ( opening wedge) Osteotomies of the Medial Cuneiform
• Evans Lengthening Osteotomies
• Subtalar Fusion
• First Metatarsal-Cuneiform Lengthening Arthrodesis
• Calcaneocuboid Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1000T-CGPB
In Commercial Distribution
- 00810005669382 ()
- Surgical tissue compression device
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0065
In Commercial Distribution
- D83600650 ()
0065
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0064
In Commercial Distribution
- D83600640 ()
0064
- Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0063
In Commercial Distribution
- D83600630 ()
0063
- Dental composite resin