FDA.reportPublic FDA data

Howard Leight

Primary DI
00033552025221
Brand
Howard Leight
Company
SPERIAN HEARING PROTECTION, LLC
Model
IMPACT SPORT
Catalog number
R-02522
Device description
Impact Sport Sound Amplification Electronic Earmuff, Purple
Published
2020-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EWEProtector, Hearing (Circumaural)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWEProtector, Hearing (Circumaural)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00033552025221PrimaryGS10
20033552025225Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00033552025221000335520252210335520252210033552025221
2003355202522520033552025225

GMDN Terms#

Term, Definition table
TermDefinition
Acoustic earmuffsA device that is worn over the ears to protect the user's hearing from excessive levels of noise, typically when using noisy machinery. It consists of a two hard plastic cups (one to fit over each ear) that are lined with sound attenuating material with soft ear cushions/pads on the outer rim. The cups are held together with a headband that is sprung to gently hold the cups against the side of the head. Included are types that also provide warmth and which are used for cold outdoor weather conditions. Also known as ear defenders. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00-20C to 60C <90% Humidity

Regulatory Flags#

DUNS number
014982953
Device count
6
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00033552003717Howard LeightMAXMAX-1-D2020-07-31
00033552011521Howard LeightMATRIX MTX-1-OR2020-07-31
00033552013532Howard LeightMatrixMTX-1-OR-D2020-07-31
00033552015215Howard Leight by HoneywellAirSoftR-015212020-09-11
00033552016847Howard Leight by HoneywellAquaSealR-016842020-09-11
00033552022374Howard Leight by HoneywellTRUSTFIT PODR-022372020-09-11
00033552000242Howard Leight by HoneywellAIRSOFTAS-12020-09-22
00033552022053Howard Leight by HoneywellTRUSTFIT TRUSTFITPOD-12020-09-21
00033552022367Howard Leight by HoneywellTRUSTFIT R-022362020-09-11
10033552014345Howard LeightLeight SourceMAX-LS4E2020-08-14
00033552011101Howard LeightSuper LeightR-011102020-07-31
00033552011804Howard Leight by HoneywellSuper LeightR-011802020-07-31
00033552015178Howard LeightLeight PlugsR-015172020-07-31
00033552015185Howard LeightLeight PlugsR-015182020-07-31
00033552016694Howard Leight by HoneywellSuper LeightR-016692020-07-31
00033552016779Howard Leight by HoneywellSuper Leight R-016772020-07-31
00033552016809Leight SleepersHoward LeightR-016802020-07-31
00033552016816Howard LeightLeight SleepersR-016812020-07-31
00033552016823Howard LeightMulti LeightR-016822020-07-31
00033552017578Howard Leight by HoneywellSuper LeightR-017572020-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628725095318Micro MinimuffsCHS USA Inc.EWE2026-01-07
50628725095313Micro MinimuffsCHS USA Inc.EWE2026-01-07
00628725095295MiniMuffsCanadian Hospital Specialties LimitedEWE2025-04-11
50628725095290MiniMuffsCanadian Hospital Specialties LimitedEWE2025-04-11
10194484320734CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
10194484320741CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
20194484320731CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
20194484320748CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
00860008980700DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980717DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980724DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980731DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980748DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980755DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980762DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980779DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980786DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980793DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00033552000242Howard Leight by HoneywellSPERIAN HEARING PROTECTION, LLCEWE2020-09-22
00033552022053Howard Leight by HoneywellSPERIAN HEARING PROTECTION, LLCEWE2020-09-21
00033552015260 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552015307 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552019022Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552022312Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
07312550119945Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
10033552015267 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
10033552015304 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552019026Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552022316Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552025225Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31