BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BeamMed

    DI: 07299012704119 · Model: OMNISENSE 7000 ULTRASOUND BONE SONOMETER · BEAMMED LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BeamMed
    Primary DI
    07299012704119
    Version / Model
    OMNISENSE 7000 ULTRASOUND BONE SONOMETER
    Company Name
    BEAMMED LTD
    Labeler DUNS
    534155155
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-25
    Public Version
    5
    Public Version Date
    2020-07-08
    Public Version Status
    Update
    Public Device Record Key
    2b3bffbb-8cf1-430c-a077-01a885915683
    Distribution End Date
    2020-07-07

    Device Description

    "Omnisense 7000: The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. It is comprised of a Main Unit and small hand held probes, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia. Reference databases are provided for measurements at each of the skeletal sites. Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated. Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young adults), Z-score values (units of standard deviations relative to age and gender matched population reference values), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Omnisense may report the Osteoporosis, Risk Index (ORI™), which combines the individual results into a single clinical index. No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: Omnisense is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probe - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR probe - used for bone strength assessment at the metatarsal The probes can be supplied with Omnisense 7000 and/or Omnisense 8000. Omnisense models: S – Adult application P – Pediatric application Premier - Premature

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MUA Bone Sonometer

    GMDN Terms

    Code Name
    40779 Bone absorptiometric ultrasound system

    Identifiers

    Type ID
    Primary 07299012704119