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Integra® Ruggles®-Redmond™ Fukushima-Day Retraction System, 16-1/4", U Bar
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
R9103
In Commercial Distribution
- M274R91031 ()
- 10381780155119 ()
R9103
- Surgical retractor/retraction system blade, reusable
EXP C U/L 5-5 L 3-3 EXP M L 4,5 HK 345
Gc Orthodontics America Inc.
11/20-1CC5-1120
In Commercial Distribution
- D78811201CC511201 ()
11/20-1CC5-1120
- Orthodontic bracket, ceramic
SR Vivodent S DCL 6er O A13 A3, SR Vivodent S DCL 6er O A12 A3, SR Vivodent S DCL 6er O A66 A3, SR Vivodent S DCL 6er U A5 A3, SR Vivodent S DCL 6er U A6 A3, SR Vivodent S DCL 6er U A7 A3, SR Orthotyp S DCL 8er O N3U A3, SR Orthotyp S DCL 8er U N3L A3, SR Orthotyp S DCL 8er O N4U A3, SR Orthotyp S DCL 8er U N4L A3, SR Orthotyp S DCL 8er O N5U A3, SR Orthotyp S DCL 8er U N5L A3
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
742146
Not in Commercial Distribution
- DIVO7421460 ()
- DIVO7421461 ()
742146
- Resin artificial teeth
SR Vivodent S PE 6er O A13 2A, SR Vivodent S PE 6er O A12 2A, SR Vivodent S PE 6er O A66 2A, SR Vivodent S PE 6er U A5 2A, SR Vivodent S PE 6er U A6 2A, SR Vivodent S PE 6er U A7 2A, SR Orthotyp S PE 8er O N3U 2A, SR Orthotyp S PE 8er U N3L 2A, SR Orthotyp S PE 8er O N4U 2A, SR Orthotyp S PE 8er U N4L 2A, SR Orthotyp S PE 8er O N5U 2A, SR Orthotyp S PE 8er U N5L 2A
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
742135
Not in Commercial Distribution
- DIVO7421350 ()
- DIVO7421351 ()
742135
- Resin artificial teeth
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.
3.X
Not in Commercial Distribution
- B553202258OTC0 ()
- 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
- B553202058OTC0 ()
- 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
CERAM BRACK 022 W/HKS 24/PK MBT U/L 3X3 4-6 METAL KIT
PATTERSON DENTAL SUPPLY, INC.
070416008
In Commercial Distribution
- D6620704160080 ()
- Orthodontic bracket, ceramic
Artifical Teeth, resin
Kulzer GmbH
66037089
In Commercial Distribution
- J014660370890 ()
66037089
- Resin artificial teeth