ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680200
• Version / Model: Cabo Elbow Left
• Catalog Number: CE001L
• 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: 3
• Public Version Date: 2024-07-25
• Public Version Status: Update
• Public Device Record Key: 9e85432d-37c3-4139-8213-0330ea26081f

Device Description

This universal-fit range-of-motion elbow brace is a great alternative to casting or repetitive splinting. Designed to treat any injury in which a limited range of elbow motion is desired. Features: Adjustable straps to fit universally. Lightweight design for comfort and ease of use. ROM hinge features flexion settings from 0-120 degrees and extension settings from 0-90 degrees.

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
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12096	Elbow immobilizer	A non-rigid external device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113680200	GS1

Customer Contacts

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