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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
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 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
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 - Grey
In Commercial Distribution
- 62088-0000-35 ()
- 10862088000351 ()
InPen-100NN-GY / MMT-105NNGY
- Empty self-injector, mechanical
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 - Blue
In Commercial Distribution
- 62088-0000-34 ()
- 10862088000344 ()
InPen-100NN-BL / MMT-105NNBL
- Empty self-injector, mechanical
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.
Lilly - Pink
In Commercial Distribution
- 62088-0000-33 ()
- 10862088000337 ()
InPen-100EL-PK / MMT-105ELPK
- Empty self-injector, mechanical
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.
Lilly - Grey
In Commercial Distribution
- 62088-0000-32 ()
- 10862088000320 ()
InPen-100EL-GY / MMT-105ELGY
- Empty self-injector, mechanical
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.
Lilly - Blue
In Commercial Distribution
- 62088-0000-31 ()
- 10862088000313 ()
InPen-100EL-BL / MMT-105ELBL
- Empty self-injector, mechanical
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.
The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.
In particular, the device is intended to provide:
Linear distance measurements of anatomical structures,
Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,
Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies,
Measurement of brightness ratio between structures and in particular between the liver and the kidney,
Estimates of speed of sound in the liver.
The device is composed of:
- Hepatoscope App
- an external ultrasound E.C5-1 Probe(accessory) dedicated to abdominal imagingand liver imaging. The E.C5-1 Probe is a curvilinear low-frequency ultrasound imaging
probe that connects to the Laptop (SelectedHost) via a dedicated USB-C lead cable,consisting of an electrodynamic vibratorlocated at its back, which generates transient
vibrations.
E-SCOPICS
eC5-1 probe
In Commercial Distribution
- 03770023859004 ()
- Hand-held ultrasound imaging system, body-surface
- Hepatic ultrasound elastography system applicator
roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices.
rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location.
rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard.
The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times.
The full-control accessibility to higher risk modalities with physical switches (CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.
roclub GmbH
1
Not in Commercial Distribution
- 09120138870014 ()
-
- Radiology DICOM image processing application software