ManaEZ Thumb Spica Right, Extra Large

Basic Information

• Brand Name: ManaEZ Thumb Spica Right, Extra Large
• Primary DI: 00810113684147
• Version / Model: EZTS3809R-XL
• Catalog Number: EZTS3809R-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: 1
• Public Version Date: 2025-10-27
• Public Version Status: New
• Public Device Record Key: 87988009-28e6-4bbd-a666-bf8d7eb4bcd5

Device Description

The ManaEZ Thumb Spica is an orthosis that includes our patent pending pull system. Low-profile, high-quality lace design system Extra-large size 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
41044	Wrist/hand/finger stable-position orthosis	An externally applied orthopaedic appliance or apparatus designed to maintain both the transverse and longitudinal arches of the hand, and to hold the thumb in a functional position. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113684147	GS1

Customer Contacts

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