MEDZAH ELBOW SPLINT, EXTRA SMALL

Basic Information

• Brand Name: MEDZAH ELBOW SPLINT, EXTRA SMALL
• Primary DI: 00860010472163
• Version / Model: MED-1001
• Company Name: Medzah Industries
• Labeler DUNS: 114193536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-23
• Public Version: 1
• Public Version Date: 2024-01-31
• Public Version Status: New
• Public Device Record Key: 0776ce0f-a225-4f0e-a936-ce77b676b1a8

Device Description

Immobilize the elbow, without preventing arm movement. Ideal for covering and protecting arm IV sites. Constructed of nylon laminated foam with reinforced aluminum stays. Hook-and-loop tab closures for easy application and removal. Extra Small Size.

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: 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
IQI	Orthosis, Limb Brace	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41053	Elbow orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010472163	GS1
Package	10860010472160	GS1	Case	50	In Commercial Distribution

Customer Contacts

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