Home GUDID 10860001719397 OsteoProbe Measurement Kit
Primary DI 10860001719397
Brand OsteoProbe Measurement Kit
Company Active Life Scientific, Inc.
Model OPD-907
Catalog number OPD-907
Device description OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block
Published 2021-12-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QGQ Bone Indentation Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QGQ Bone Indentation Device Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860001719397 Package GS1 5 In Commercial Distribution 00860001719390 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860001719397 10860001719397 00860001719390 00860001719390 860001719390 0860001719390
GMDN Terms# Term, Definition table Term Definition Bone microindentation resistance measurement system An electrically-powered assembly of devices intended to assess cortical bone quality by measuring its resistance to microindentation for identification of bone deficiencies missed by imaging that may increase bone fragility and fracture risk. It consists of a handpiece with connections to an adaptor and computing device where data is analysed and displayed; it is used with a single-use, patient-contact handpiece tip (not included).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 71 KiloPascal 101 KiloPascal Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 30 Degrees Celsius Storage Environment Atmospheric Pressure 71 KiloPascal 101 KiloPascal Storage Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 004386740 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860001719390 OsteoProbe Measurement Kit OPD-907 OPD-907 2021-12-28
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860001719390 OsteoProbe Measurement Kit Active Life Scientific, Inc. QGQ 2021-12-28
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