Bindex

Primary DI
06430065790013
Brand
Bindex
Company
Bone Index Finland Oy
Model
BI-2
Published
2017-01-16
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
MUABone Sonometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUABone SonometerRadiology2

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
06430065790013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430065790013064300657900136430065790013

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure600 millibar1060 millibar
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius

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
06430065790020Bindex MeasureBI-412017-05-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052461860053Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860060Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860084Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
08052461860091Echolight S.p.a.ECHOLIGHT SPAMUA2025-04-09
06430065790068Bindex BI-2 KitBone Index Finland OyMUA2024-02-01
08052461860046Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-05
08052461860022Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-04
08052461860039Echolight S.p.a.ECHOLIGHT SPAMUA2021-03-04
08052461860008Echolight S.p.a.ECHOLIGHT SPAMUA2019-11-25
08052461860015Echolight S.p.a.ECHOLIGHT SPAMUA2019-11-25
06430065790051Bindex BI-2 KitBone Index Finland OyMUA2018-01-03
06430065790037Bindex BI-2 KitBone Index Finland OyMUA2017-05-31
06430065790044Bindex BI-2 KitBone Index Finland OyMUA2017-05-31
07290012704109BeamMedBEAMMED LTDMUA2017-01-25
07299012704119BeamMedBEAMMED LTDMUA2017-01-25
06430065790006BindexBone Index Finland OyMUA2017-01-16
00840682116978Achilles EXPIIGE Medical Systems (China) Co.,Ltd.MUA2016-06-27