Handy Solutions

Basic Information

• Brand Name: Handy Solutions
• Primary DI: 00024291266181
• Version / Model: 26618
• Company Name: NAVAJO MANUFACTURING COMPANY
• Labeler DUNS: 136941411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-15
• Public Version: 1
• Public Version Date: 2023-06-23
• Public Version Status: New
• Public Device Record Key: c658c719-68bf-443e-bca1-90550d5a4d32

Device Description

Mack's Earplugs - 2 Pair in Clamshell Case

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: No
• Has Manufacturing Date: No
• 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
EWD	Protector, hearing (insert)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
41230	Earplugs, reusable	A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00024291266181	GS1

Customer Contacts

• Phone: [phone] ext. 8265
• Email: [email protected]