FDA.reportPublic FDA data

Bindex Measure

Primary DI
06430065790020
Brand
Bindex Measure
Company
Bone Index Finland Oy
Model
BI-41
Device description
Measuring stick for defining the standard location for Bindex measurement.
Published
2017-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTYTape, Measuring, Rulers And Calipers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161971000Bindex BI-2Bone Index Finland , Ltd.2017-01-09MUA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430065790020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430065790020064300657900206430065790020

GMDN Terms#

Term, Definition table
TermDefinition
Bone absorptiometric ultrasound systemAn 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358504481696info@boneindex.fi

Regulatory Flags#

DUNS number
539828676
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430065790068Bindex BI-2 Kitv4 (w/o Gel)2024-02-01
06430065790013BindexBI-22017-01-16
06430065790037Bindex BI-2 Kitv1 (w/ Gel)2017-05-31
06430065790044Bindex BI-2 Kitv2 (w/o Gel)2017-05-31
06430065790051Bindex BI-2 Kitv3 (w/o Gel)2018-01-03
06430065790006BindexBI-1002017-01-16

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