Leader

GUDID 00096295133882

Soft Foam Earplugs 10 Pairs

CIRRUS HEALTHCARE PRODUCTS LLC

Earplugs, single-use

• Primary Device ID: 00096295133882
• NIH Device Record Key: a0256a74-fac7-4dd6-935c-ff8e5b389539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leader
• Version Model Number: 81025
• Company DUNS: 809994163
• Company Name: CIRRUS HEALTHCARE PRODUCTS LLC
• Device Count: 1
• DM Exempt: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295133882 [Primary]
GS1	10096295133889 [Package]; Package: Unit [1 Units]; In Commercial Distribution
GS1	50096295133887 [Package]; Contains: 10096295133889; Package: Master [144 Units]; In Commercial Distribution

FDA Product Code

• EWD: Protector, Hearing (Insert)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

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