All Terrain Mountainner Knee Walker Single Folding 12" / 12"

Basic Information

• Brand Name: All Terrain Mountainner Knee Walker Single Folding 12" / 12"
• Primary DI: 00840117334427
• Version / Model: 10218
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-15
• Public Version: 2
• Public Version Date: 2024-10-09
• Public Version Status: Update
• Public Device Record Key: 870edb88-b555-4a8f-af7e-ca091160535c

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
66923	Knee walker	A non-powered mobility aid in the form of a framework with wheels, a padded knee rest, and a steering handle directly connected to the front wheels, intended to be operated by a person with a lower leg injury who propels the device by pushing on the ground with one foot while resting the knee of the injured leg on the knee rest. Also known as a knee scooter, it is intended as an alternative to crutches and walking frames for patients with non-weight-bearing lower leg injuries.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840117334427	GS1