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

• 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