Leader

Basic Information

• Brand Name: Leader
• Primary DI: 00096295133882
• Version / Model: 81025
• Company Name: CIRRUS HEALTHCARE PRODUCTS LLC
• Labeler DUNS: 809994163
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-21
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: a0256a74-fac7-4dd6-935c-ff8e5b389539

Device Description

Soft Foam Earplugs 10 Pairs

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
35024	Earplugs, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00096295133882	GS1
Package	10096295133889	GS1	Unit	1	In Commercial Distribution
Package	50096295133887	GS1	Master	144	In Commercial Distribution