Howard Leight R-01110

GUDID 00033552011101

Super Leight Pre-Shaped Foam Earplugs Carrying Case NRR 33

SPERIAN HEARING PROTECTION, LLC

Earplugs, single-use

• Primary Device ID: 00033552011101
• NIH Device Record Key: 13a6f4ae-3d73-46f7-80cc-04f2a2bbfb4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Howard Leight
• Version Model Number: Super Leight
• Catalog Number: R-01110
• Company DUNS: 014982953
• Company Name: SPERIAN HEARING PROTECTION, 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: false
• Lot Batch: false
• 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	00033552011101 [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: 2020-08-10
• Device Publish Date: 2020-07-31

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