ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680477
• Version / Model: ManaEZ Crutch, Black
• Catalog Number: EZCRUTCH01
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-20
• Public Version: 1
• Public Version Date: 2022-06-28
• Public Version Status: New
• Public Device Record Key: 2f8bdc83-b3b8-4685-b9b5-313b477c27e3

Device Description

ManaMed's crutches are comfortable and lightweight, comes in pairs. Universal Sizing Height Adjustable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
IPR	Crutch	Physical Medicine	890.3150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31113	Elbow crutch	A staff-like mobility aid designed to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and a non-horizontal plastic or metal cuff that wraps around the forearm. The handgrip is typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). It may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is commonly used by long-term crutch users because of its lightweight and energy preservation qualities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113680477	GS1