Howard Leight R-01902

GUDID 20033552019026

Impact Pro High NRR Sound Amplification Electronic Earmuff, Black & Gray

SPERIAN HEARING PROTECTION, LLC

Acoustic earmuffs

• Primary Device ID: 20033552019026
• NIH Device Record Key: 628c9b54-88c8-4b78-89d3-4107919d401f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Howard Leight
• Version Model Number: Impact Pro
• Catalog Number: R-01902
• Company DUNS: 014982953
• Company Name: SPERIAN HEARING PROTECTION, LLC
• Device Count: 6
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C
• Special Storage Condition, Specify: Between 0 and 0 *-20C to 60C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00033552019022 [Primary]
GS1	20033552019026 [Unit of Use]

FDA Product Code

• EWE: Protector, Hearing (Circumaural)

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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