OsteoProbe Measurement Kit

Basic Information

• Brand Name: OsteoProbe Measurement Kit
• Primary DI: 00860001719390
• Version / Model: OPD-907
• Catalog Number: OPD-907
• Company Name: Active Life Scientific, Inc.
• Labeler DUNS: 004386740
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-28
• Public Version: 1
• Public Version Date: 2022-01-05
• Public Version Status: New
• Public Device Record Key: 6b05478c-9df6-4551-b6b2-344d0f28df79

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QGQ	Bone Indentation Device	Orthopedic	888.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65718	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10860001719397	GS1	Case	5	In Commercial Distribution
Primary	00860001719390	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN210013	000

Storage Conditions

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