AccessGUDID - DEVICE: Bindex BI-2 Kit (06430065790068)

GUDID

Device Identifier (DI) Information

Brand Name: Bindex BI-2 Kit
Version or Model: v4 (w/o Gel)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bone Index Finland Oy

Primary DI Number: 06430065790068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 539828676 *Terms of Use

Device Description: Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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 [?]
K211350	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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between 15 and 40 Degrees Celsius
Handling Environment Temperature: between 15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f22b6a02-0349-422f-a709-b4239b03ca82
Public Version Date: February 09, 2024
Public Version Number: 1
DI Record Publish Date: February 01, 2024