Leader

GUDID 00096295138634

Ultra-Soft Silicone Earplugs 6 Pairs

CIRRUS HEALTHCARE PRODUCTS LLC

Earplugs, single-use

• Primary Device ID: 00096295138634
• NIH Device Record Key: ea113338-0084-4fb5-9c1f-ea87c8373ce1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leader
• Version Model Number: 41344
• Company DUNS: 809994163
• Company Name: CIRRUS HEALTHCARE PRODUCTS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295138634 [Primary]

FDA Product Code

• EWD: Protector, Hearing (Insert)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-19
• Device Publish Date: 2019-09-11

On-Brand Devices [Leader]

• 00096295133882: Soft Foam Earplugs 10 Pairs
• 00096295133875: Earplugs Flight Ear Protection 1 Pair
• 00096295138634: Ultra-Soft Silicone Earplugs 6 Pairs
• 00096295138498: Children's Silicone Earplugs