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ASC Astra® EV-compatible 3.0mm Titanium Blank
Preat Corporation
9006465
In Commercial Distribution
- 00842092183137 ()
9006465
- Dental implant suprastructure, permanent, preformed
ASC Keystone TiLobe®-compatible 5.0mm Titanium Blank
Preat Corporation
9005965
In Commercial Distribution
- 00842092183120 ()
9005965
- Dental implant suprastructure, permanent, preformed
ASC Keystone TiLobe®-compatible 4.1mmTitanium Blank
Preat Corporation
9005865
In Commercial Distribution
- 00842092183113 ()
9005865
- Dental implant suprastructure, permanent, preformed
ASC Keystone TiLobe®-compatible 3.5mmTitanium Blank
Preat Corporation
9005765
In Commercial Distribution
- 00842092183106 ()
9005765
- Dental implant suprastructure, permanent, preformed
ASC Legacy 3.5mm-Compatible Titanium Blank
Preat Corporation
9005665
In Commercial Distribution
- 00842092183090 ()
9005665
- Dental implant suprastructure, permanent, preformed
ASC BioHorizons®-compatible 4.5mm Titanium Blank
Preat Corporation
9005565
In Commercial Distribution
- 00842092183083 ()
9005565
- Dental implant suprastructure, permanent, preformed
ASC BioHorizons®-compatible 3.5mm Titanium Blank
Preat Corporation
9005465
In Commercial Distribution
- 00842092183076 ()
9005465
- Dental implant suprastructure, permanent, preformed
ASC Legacy™ 3.0mm-Compatible Titanium Blank
Preat Corporation
9005365
In Commercial Distribution
- 00842092183069 ()
9005365
- Dental implant suprastructure, permanent, preformed
ASC Hiossen® HG-compatible Mini Titanium Blank
Preat Corporation
9005065
In Commercial Distribution
- 00842092183052 ()
9005065
- Dental implant suprastructure, permanent, preformed
ASC BioHorizons®-compatible 3.0 mm Engaging Titanium Blank
Preat Corporation
9005265
In Commercial Distribution
- 00842092183045 ()
9005265
- Dental implant suprastructure, permanent, preformed
ASC NobelActive™/Conical-compatible 3.0mm Titanium Blank
Preat Corporation
9004765
In Commercial Distribution
- 00842092183038 ()
9004765
- Dental implant suprastructure, permanent, preformed
ASC MegaGen AnyRidge®-compatible RP Titanium Blank
Preat Corporation
9004465
In Commercial Distribution
- 00842092183021 ()
9004465
- Dental implant suprastructure, permanent, preformed
ASC Neoss®-compatible 3.5-6.0 mm Titanium Blank
Preat Corporation
9004165
In Commercial Distribution
- 00842092183014 ()
9004165
- Dental implant suprastructure, permanent, preformed
ASC Astra®-compatible Lilac 4.5/5.0 mm Titanium Blank
Preat Corporation
9002265
In Commercial Distribution
- 00842092183007 ()
9002265
- Dental implant suprastructure, permanent, preformed
ASC Astra®-compatible Aqua 3.5/4.0 mm Titanium Blank
Preat Corporation
9002165
In Commercial Distribution
- 00842092182994 ()
9002165
- Dental implant suprastructure, permanent, preformed
ASC Astra®-compatible 3.0mm Titanium Blank
Preat Corporation
9002065
In Commercial Distribution
- 00842092182987 ()
9002065
- Dental implant suprastructure, permanent, preformed
ASC Biomet 3i Certain®-compatible 6.0 mm Titanium Blank
Preat Corporation
9001965
In Commercial Distribution
- 00842092182970 ()
9001965
- Dental implant suprastructure, permanent, preformed
ASC Biomet 3i Certain®-compatible 5.0 mm Titanium Blank
Preat Corporation
9001865
In Commercial Distribution
- 00842092182963 ()
9001865
- Dental implant suprastructure, permanent, preformed
ASC Biomet 3i Certain®-compatible 4.1 mm Titanium Blank
Preat Corporation
9001765
In Commercial Distribution
- 00842092182956 ()
9001765
- Dental implant suprastructure, permanent, preformed
ASC Biomet 3i Certain®-compatible 3.4 mm Titanium Blank
Preat Corporation
9001665
In Commercial Distribution
- 00842092182949 ()
9001665
- Dental implant suprastructure, permanent, preformed
ASC Straumann Bone Level NC-Compatible Titanium Blank
Preat Corporation
9001565
In Commercial Distribution
- 00842092182932 ()
9001565
- Dental implant suprastructure, permanent, preformed
ASC Straumann® BL-compatible RC Titanium Blank
Preat Corporation
9001465
In Commercial Distribution
- 00842092182925 ()
9001465
- Dental implant suprastructure, permanent, preformed
ASC Straumann® TL-compatible RN Titanium Blank
Preat Corporation
9001265
In Commercial Distribution
- 00842092182918 ()
9001265
- Dental implant suprastructure, permanent, preformed
ASC NobelActive™/Conical-compatible RP Titanium Blank
Preat Corporation
9000965
In Commercial Distribution
- 00842092182901 ()
9000965
- Dental implant suprastructure, permanent, preformed
ASC NobelActive™/Conical-compatible NP Titanium Blank
Preat Corporation
9000865
In Commercial Distribution
- 00842092182895 ()
9000865
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible 6.0 mm Titanium Blank
Preat Corporation
9000765
In Commercial Distribution
- 00842092182888 ()
9000765
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible WP Titanium Blank
Preat Corporation
9000665
In Commercial Distribution
- 00842092182871 ()
9000665
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible RP Titanium Blank
Preat Corporation
9000565
In Commercial Distribution
- 00842092182864 ()
9000565
- Dental implant suprastructure, permanent, preformed
ASC NobelBiocare™ Tri-Lobe-compatible NP Titanium Blank
Preat Corporation
9000465
In Commercial Distribution
- 00842092182857 ()
9000465
- Dental implant suprastructure, permanent, preformed
ASC Zimmer TSV 5.7mm-Compatible Titanium Blank
Preat Corporation
9000365
In Commercial Distribution
- 00842092182840 ()
9000365
- Dental implant suprastructure, permanent, preformed
ASC Hiossen® HG-compatible Standard Titanium Blank
Preat Corporation
9005165
In Commercial Distribution
- 00842092182833 ()
9005165
- Dental implant suprastructure, permanent, preformed
ASC Zimmer TSV 4.5mm-Compatible Titanium Blank Kit contains 1 ASC Zimmer® TSV-compatible 4.5 mm Titanium Blank and 2 ASC Zimmer® TSV-compatible 3.5mm/4.5mm/5.7mm Titanium Screws
Preat Corporation
9000265
In Commercial Distribution
- 00842092182826 ()
- 10842092182823 ()
9000265
- Dental implant suprastructure, permanent, preformed
ASC Zimmer® TSV-compatible 3.5mm Titanium Blank Kit contains 1 ASC Zimmer® TSV-compatible 3.5mm Titanium Blank and 2 ASC Zimmer® TSV-compatible 3.5mm/4.5mm/5.7mm Titanium Screws
Preat Corporation
9000165
In Commercial Distribution
- 00842092182819 ()
- 10842092182816 ()
9000165
- Dental implant suprastructure, permanent, preformed
The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5900-01-300
Not in Commercial Distribution
- 00817491021885 ()
FG-5900-01-300
- Implantable glucose monitoring system
Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5700-01-300
Not in Commercial Distribution
- 00817491021878 ()
FG-5700-01-300
- Implantable glucose monitoring system
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202257OTC0 ()
- Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution
- B553202057OTC0 ()
- Self-care monitoring/reporting software
The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5905-01-300
In Commercial Distribution
- 00817491023513 ()
FG-5905-01-300
- Implantable glucose monitoring system
Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5705-01-300
In Commercial Distribution
- 00817491023506 ()
FG-5705-01-300
- Implantable glucose monitoring system
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
SWEETSPOT DIABETES CARE, INC.
350-0010
Not in Commercial Distribution
- B059POW3500010 ()
350-0010
- Noninvasive interstitial fluid glucose monitoring device