VERASENSE

Basic Information

• Brand Name: VERASENSE
• Primary DI: 00816818021348
• Version / Model: VERASENSE for Stryker Triathlon size 7
• Catalog Number: SYK-TRCR 07
• Company Name: ORTHOSENSOR INC
• Labeler DUNS: 005788130
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-02
• Public Version: 8
• Public Version Date: 2023-07-10
• Public Version Status: Update
• Public Device Record Key: dfa0d5d6-feb8-4ef2-a058-4c7d9604b70e
• Distribution End Date: 2023-06-30

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58988	Arthroplasty force sensor	An electronic device designed for use during arthroplasty to facilitate assessment of joint function during implantation of prosthesis components, typically to evaluate bone resection lines, prosthesis size and positioning, and/or soft tissue tension. It is dedicated to a specific joint or type of prosthesis (e.g., total knee, reverse shoulder) and consists of a transducer pad for insertion between opposing joint surfaces. It may have an integrated digital display or communicate with an external display unit; some types include a noninvasive analogue-to-digital converter and image display controller. It is typically available as a left or right version. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816818021348	GS1

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 47 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 100 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 37 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 36 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius