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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.
0062
In Commercial Distribution
- D83600620 ()
0062
- Dental composite resin
ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; Security ; AM15E patient cable; IEC 13 wire, 15-lead lead set with banana plugs and EU po
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094265446 ()
ELI380-ACS44
- Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; WAM Wireless Acquisition Module; IEC 10 wire, 12-lead lead set with banana plugs and EU p
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094265439 ()
ELI380-ACX12
- Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel ECG- Color LCD 17" display with 1280 x 1024 res, English keyboard, AC or li-ion battery operation inc; 1 starter pck paper (Smart Paper 8.27" x 11"), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current sfw; adult and pediatric interp; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; Patient Demographic Query (PDQ) + Security; WAM Wireless Acquisition Module; IEC 10 wire, 12-lead lead set with banana plugs and EU power cord
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094319439 ()
ELI380-ACQ12
- Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; AM12 Wired Acquisition Module; IEC 10 wire, 12-lead lead set with banana plugs and EU pow
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094265422 ()
ELI380-ACX22
- Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; AM12 Wired Acquisition Module (for use with Quickels Decapus III or greater); IEC 10 wire
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094265415 ()
ELI380-ACX32
- Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; AM15E patient cable; IEC 13 wire, 15-lead lead set with banana plugs and EU power cord
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094265408 ()
ELI380-ACX44
- Electrocardiograph, professional, multichannel
ELI380 12-Lead Multi-Channel Electrocardiograph - Color LCD 17 in. display with 1280 x 1024 resolution, Russian keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; ; AM15E patient cable; IEC 13 wire, 15-lead lead set with banana plugs and EU power cord
WELCH ALLYN, INC.
901133
In Commercial Distribution
- 00732094265385 ()
ELI380-BCX44
- Electrocardiograph, professional, multichannel
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or forhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301830# hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188863 ()
- Pressure,30-40 mmHg
923CSSM99
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fithttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301826#ted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188849 ()
- Pressure,30-40 mmHg
923CMSM99
- Compression/pressure sock/stocking, single-use