AccessGUDID - DEVICE: BeamMed (07290012704109)

GUDID

Device Identifier (DI) Information

Brand Name: BeamMed
Version or Model: Sunlight MiniOmni Ultrasound Bone Sonometer
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BEAMMED LTD

Primary DI Number: 07290012704109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534155155 *Terms of Use

Device Description: "Sunlight MiniOmni: The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. Sunlight MiniOmni Ultrasound Bone Sonometer is a modified version of company's well- established Sunlight Omnisense systems*. Sunlight MiniOmni is based on the Sunlight Omnipath™ technology already CE marked and approved by the FDA (PMA). It is comprised of a Main Unit and the same hand held probes as used with other BeamMed's Bone Sonometers, 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, Sunlight MiniOmni 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. Sunlight MiniOmni reports the bone SOS, together with the Z-score (units of standard deviations relative to age and gender matched population reference values), for adults also as a T-score values (units of standard deviations relative to population reference values of healthy young adults), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Sunlight No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: MiniOmni is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probes - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40779	Bone absorptiometric ultrasound system	An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ultrasound beam to an anatomical region of interest. Information obtained from detection and analysis of resulting echoes is used in calculations to estimate bone mineral density or subcutaneous fat, or to make other quantitative assessments (e.g., fracture risk). It typically incorporates an ultrasound transducer, detection electronics, a control panel, a computer, software programs, a video display, and a patient positioning system (PPS).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUA	Bone Sonometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110646	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99adf171-7682-461d-97d3-37351835d31d
Public Version Date: December 10, 2019
Public Version Number: 4
DI Record Publish Date: January 25, 2017