TruRize

Basic Information

• Brand Name: TruRize
• Primary DI: 07613327322569
• Version / Model: 3333
• Catalog Number: 3333-000-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 078470558
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 5cb458b5-3941-47c3-ba65-c38a2bc6e5ed

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• 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
INO	Chair, positioning, electric	Physical Medicine	890.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10796	Stand-up chair, electric	An electrically-powered device designed to support a patient with a disability (e.g., geriatric, injured, disabled) in a sitting posture and helps the person via its self-raising mechanism to both to sit down from a standing position and stand up from a sitting position. The electrically-powered features may include a seat that can be elevated and tilted forward to help the person stand, and/or a seat composed of several articulated sections that tilt to facilitate the person's activities and comfort. It is neither a stander (which is intended to support a patient in a prolonged standing position) nor a wheelchair.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327322569	GS1

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit