Steerable Knee Walker with Basket

Basic Information

• Brand Name: Steerable Knee Walker with Basket
• Primary DI: 00616784021614
• Version / Model: 10216
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-08
• Public Version: 2
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: 35279f16-7a98-465a-93cd-b9c2c61b9777

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ITJ	Walker, Mechanical	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46437	Patient/medical device walker, clinical	An all-wheeled mobility aid in the form of a high support structure designed to provide unassisted post-surgery mobilization of an adult patient while he/she is connected to essential medical devices, e.g., intravenous (IV) drip(s), infusion and/or syringe pump(s), oxygen (O2) therapy device(s) and is pushed by the patient with handgrips. It is typically made of tubular metal (stainless steel or plastic coated) and typically includes integral IV poles/hangers, height-adjustable handgrips, interchangeable elbow supports, and an O2 cylinder holder. A power board with electrical outlets and cable (cord) for connection to the mains electricity supply, when necessary, may also be included.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00616784021614	GS1