ManaEZ Wrist Right, Extra Large

Basic Information

• Brand Name: ManaEZ Wrist Right, Extra Large
• Primary DI: 00810113684178
• Version / Model: EZW3908R-XL
• Catalog Number: EZW3908R-XL
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-17
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: 7e1a8216-3a79-4641-aa92-a5ee7a84c790

Device Description

The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply the brace. Low-profile, high-quality lace design system This is the Extra-Large version to accommodate patients who do not fit the one-size-fits-most orthosis.

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: Yes
• MRI Safety: MR Unsafe
• 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
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12102	Wrist splint, reusable	A rigid external support designed to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist. The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113684178	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]