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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ANNE™ One - 00860004541707

ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.
Sibel Health Inc.
SA-002
In Commercial Distribution

  • 00860004541707 ()


  • Wearable multiple physiological parameter recorder, reusable

Medic Therapeutics - 00860004483915

Blood Pressure Cuff for the purpose of determining the subject's blood pressure. Designed for use on the wrist.
HUB EMERGENCY SERVICES, LLC
MT-WBPM-001
In Commercial Distribution

  • 00860004483915 ()


  • Blood pressure cuff, reusable

Medic Therapeutics - 00860004483908

Blood Pressure Cuff for the purpose of determining the subject's blood pressure.
HUB EMERGENCY SERVICES, LLC
MT-BPM-001
In Commercial Distribution

  • 00860004483908 ()


  • Blood pressure cuff, reusable

DiamondCrown-DCDISK - 00860004379997

DiamondCrown-DCDISK(CADCAM)-98x16mm A2 - DRM-CADCAM-DISK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCDISK-98x16mm A2
In Commercial Distribution

  • 00860004379997 ()
DCDSK752

  • Dental implant suprastructure, permanent, preformed

DiamondCrown-DCDISK - 00860004379980

DiamondCrown-DCDISK(CADCAM)-98x16mm A1/B1 - DRM-CADCAM-DISK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCDISK-98x16mm A1/B1
In Commercial Distribution

  • 00860004379980 ()
DCDSK751

  • Dental implant suprastructure, permanent, preformed

DiamondCrown-DCBLOK - 00860004379973

DiamondCrown-DCBLOK(CADCAM)-I-18mm A2 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-18mm A2
In Commercial Distribution

  • 00860004379973 ()
DCBK708

  • Dental implant suprastructure, permanent, preformed

DiamondCrown-DCBLOK - 00860004379966

DiamondCrown-DCBLOK(CADCAM)-I-18mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-18mm A1/B1
In Commercial Distribution

  • 00860004379966 ()
DCBK707

  • Dental implant suprastructure, permanent, preformed

DiamondCrown-DCBLOK - 00860004379959

DiamondCrown-DCBLOK(CADCAM)-I-12mm A2 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-12mm A2
In Commercial Distribution

  • 00860004379959 ()
DCBK704

  • Dental implant suprastructure, permanent, preformed

DiamondCrown-DCBLOK - 00860004379942

DiamondCrown-DCBLOK(CADCAM)-I-12mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-12mm A1/B1
In Commercial Distribution

  • 00860004379942 ()
DCBK703

  • Dental implant suprastructure, permanent, preformed

DiamondCrown-DCBLOK - 00860004379935

DiamondCrown-DCBLOK(CADCAM)-I-10mm A2 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-10mm A2
In Commercial Distribution

  • 00860004379935 ()
DCBK702

  • Dental implant suprastructure, permanent, preformed
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