OsteoProbe Measurement Kit OPD-907

GUDID 10860001719397

OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block

Active Life Scientific, Inc.

Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system Bone microindentation resistance measurement system

• Primary Device ID: 10860001719397
• NIH Device Record Key: 6b05478c-9df6-4551-b6b2-344d0f28df79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoProbe Measurement Kit
• Version Model Number: OPD-907
• Catalog Number: OPD-907
• Company DUNS: 004386740
• Company Name: Active Life Scientific, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com
• Phone: 805 770 2600
• Email: customer.care@activelifescientific.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001719390 [Primary]
GS1	10860001719397 [Package]; Contains: 00860001719390; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210013

FDA Product Code

• QGQ: Bone Indentation Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-05
• Device Publish Date: 2021-12-28