Howard Leight R-01526

GUDID 10033552015267

Impact Sport Sound Amplification Electronic Earmuff, Hunter Green

SPERIAN HEARING PROTECTION, LLC

Acoustic earmuffs

• Primary Device ID: 10033552015267
• NIH Device Record Key: 2cc38092-7929-45bd-a32e-b39bf57b5b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Howard Leight
• Version Model Number: Impact Sport
• Catalog Number: R-01526
• Company DUNS: 014982953
• Company Name: SPERIAN HEARING PROTECTION, LLC
• Device Count: 5
• 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

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	00033552015260 [Primary]
GS1	10033552015267 [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

On-Brand Devices [ Howard Leight ]

• 10033552015304: Impact Sport Sound Amplification Electronic Earmuff, Mossy Oak Break Up/Camo
• 10033552015267: Impact Sport Sound Amplification Electronic Earmuff, Hunter Green