SEARCH RESULTS FOR: 旺财超级签折扣常见安全问题-电报@Qianmingipa8‼️贷款app企业签名.lyz(3572 results)
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
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
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 for hospitalized or institutionalized patients. This is a reusable device. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301808#
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188832 ()
- Pressure,30-40 mmHg
923CLLM99
- Compression/pressure sock/stocking, single-use
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution
- 03770018808239 ()
SBM1AA018
- Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution
- B786SBM1AA1100 ()
SBM1AA110
- Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution
- B786SBM1AA0170 ()
SBM1AA017
- Analgesic transcutaneous electrical nerve stimulation system
Expand your communication options with a set of three BIG TalkingBrix speech devices. Pressing the large colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Add strategically around the classroom or home to provide on-the-spot communication
Use together to make choices
Use with multiple individuals at one time to provide each with a unique communication message
Features
High-quality sound suitable for almost any environment
Long-lasting rechargeable battery
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the BIG TalkingBrix. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device
Ablenet, Inc.
10000050
In Commercial Distribution
- 00850011150184 ()
10000050
- Assistive speech generator
Expand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Add strategically around the classroom or home to provide on-the-spot communication
Use together to make choices
Use with multiple individuals at one time to provide each with a unique communication message
Features
High-quality sound suitable for almost any environment
Long-lasting rechargeable battery
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000032
In Commercial Distribution
- 00186648000524 ()
10000032
- Assistive speech generator
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
OCULOCARE medical AG
3.2.12
In Commercial Distribution
- EOMA32120 ()
- Vision self-testing software
The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Use for yes and no responses
Choose between two options of food, drink, or activities
Provide a way to make two unique requests like "I need help" and "I'm done"
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000045
In Commercial Distribution
- 00850011150108 ()
10000045
- Assistive speech generator
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Provide a unique response to a question like "What is the weather like outside?"
Respond to an assessment
Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty"
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution
- 00186648000531 ()
10000028
- Assistive speech generator
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments
The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partialhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=536963#ly or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap.
The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 5824T(II)
Not in Commercial Distribution
- 08806195923108 ()
- Ø5.8X4.0(2.0)mm
SAC 5824T(II)
- Screw endosteal dental implant, two-piece
Move into multi-message communication with the BIG Step-by-Step speech device. Activate the large colored top to play the first message. When done, activate the top again to play another message. New sequences of messages are easily and quickly recorded to the BIG Step-by-Step on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Record pages of a book to tell a story
Count from 1 to 10
Ask a series of questions
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the BIG Step-by-Step. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000043
In Commercial Distribution
- 00850011150085 ()
10000043
- Assistive speech generator
Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Request like "I want" or "I need help"
Participate in an activity with "turn the page" or "It's your turn"
Tell your classmates what you did over the weekend during a morning meeting
Add communication to a switch controlled toy or applianceg
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the LITTLEmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000042
In Commercial Distribution
- 00850011150078 ()
10000042
- Assistive speech generator
Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Request like "I want" or "I need help"
Participate in an activity with "turn the page" or "It's your turn"
Tell your classmates what you did over the weekend during a morning meeting
Add communication to a switch controlled toy or applianceg
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000041
In Commercial Distribution
- 00850011150061 ()
10000041
- Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay
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
Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930708#reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess.
DENT ZAR, INC.
0055
In Commercial Distribution
- D83600550 ()
0055
- Orthodontic bracket adhesive
The SuperTalker FeatherTouch speech device provides an opportunity for users of all abilities to communicate. Change out the message grids to create a unique speech device with one, two, four, or eight messages. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate with one message or eight different messages.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Record messages like "turn the page", "look", "I like this", and "I want to stop" for use when reading a book
Record a single message to make a request like "I want" or "I need help"
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Interchangeable message grids for one, two, four, or eight messages that support picture symbol overlays
Symbol Overlays
Symbol overlays are not included with the SuperTalker FeatherTouch. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000031
In Commercial Distribution
- 00186648000548 ()
10000031
- Assistive speech generator
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included).
The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments. The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.
For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use. For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.
COMPANION MEDICAL, INC.
Novo - Pink
In Commercial Distribution
- 62088-0000-36 ()
- 10862088000368 ()
InPen-100NN-PK / MMT-105NNPK
- Empty self-injector, mechanical