SPERIAN HEARING PROTECTION, LLC

Address:Blv. Insurgentes No. 20551,Tijuana B.C. Mexico,MX

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Protector, Hearing (Insert) (EWD) (6) Protector, Hearing (Circumaural) (EWE) (4)

Premarket Exempt

Yes

Clear

Howard Leight - 00033552019022 Catalog Number : R-01902

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

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWE

Prescription Use : No

Device Count : 6

Howard Leight - 00033552021094 Catalog Number : FF-1

Device Description : FirmFit Uncorded Disposable Foam Earplugs

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWD

Prescription Use : No

Device Count : 1

Howard Leight - 00033552021117 Catalog Number : FF-1-D

Device Description : FirmFit Uncorded Disposable Foam Earplug Refill for Leight Source 500 Dispenser

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWD

Prescription Use : No

Device Count : 1

Howard Leight - 00033552021124 Catalog Number : FF-LS4

Device Description : FirmFit Uncorded Earplug Refill for Leight Source 400 Dispenser, 200 Pairs

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWD

Prescription Use : No

Device Count : 1

Howard Leight - 00033552021155 Catalog Number : FF-1-PB

Device Description : FirmFit Uncorded Disposable Foam Earplugs

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWD

Prescription Use : No

Device Count : 1

Howard Leight by Honeywell - 00033552022053 Catalog Number : TRUSTFITPOD-1

Device Description : TRUSTFIT POD, UNCORD

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWE

Prescription Use : No

Device Count : 1

Howard Leight - 00033552022312 Catalog Number : R-02231

Device Description : Impact Sport Bolt Sound Amplification Electronic Earmuff, Color: Orange

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWE

Prescription Use : No

Device Count : 6

Howard Leight by Honeywell - 00033552022367 Catalog Number : R-02236

Device Description : TRUSTFIT POD Uncorded Multiple-Use Earplugs

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWD

Prescription Use : No

Device Count : 1

Howard Leight by Honeywell - 00033552022374 Catalog Number : R-02237

Device Description : TRUSTFIT POD Corded Multiple-Use Earplugs utilize soft foam with dimpled tip tha TRUSTFIT POD Corded Multiple-Use Earplugs utilize soft foam with dimpled tip that collapses and can be easily pushed into the ear without the need to roll-down. The use of a contoured paddle allows for a natural fit between the finger and thumb, while a flexible stem material gently pushes the dimpled foam into the narrowing ear canal. Honeywell TRUSTFIT POD Multiple-Use Earplugs feature a Noise Reduction Rating (NRR) of 28.

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWD

Prescription Use : No

Device Count : 1

Howard Leight - 00033552025221 Catalog Number : R-02522

Device Description : Impact Sport Sound Amplification Electronic Earmuff, Purple

Device Class : U

Duns Number: 014982953

Premarket Exempt : Yes

Product Code : EWE

Prescription Use : No

Device Count : 6

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