FDA.reportPublic FDA data

Howard Leight

Primary DI
00033552003717
Brand
Howard Leight
Company
SPERIAN HEARING PROTECTION, LLC
Model
MAX
Catalog number
MAX-1-D
Device description
MAX-1 D Earplugs Cordless 33 NRR Coral LS 500 Refill
Published
2020-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EWDProtector, Hearing (Insert)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWDProtector, Hearing (Insert)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00033552003717PrimaryGS10
10033552003714Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00033552003717000335520037170335520037170033552003717
1003355200371410033552003714

GMDN Terms#

Term, Definition table
TermDefinition
Earplugs, single-useA device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device.

Regulatory Flags#

DUNS number
014982953
Device count
10
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00033552017769Howard LeightMAX USAR-017762020-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917079592WalgreensWALGREEN CO.EWD2026-02-19
10311917079599WalgreensWALGREEN CO.EWD2026-02-19
00033732000789Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732007122Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732007184Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732100786Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732107129Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732107181Mack'sMcKeon Products, Inc.EWD2025-08-05
G599103B0Aqua Plus Bulk BlueJkr Laboratories, Inc.EWD2025-02-07
G599103R0Aqua Plus Bulk RedJkr Laboratories, Inc.EWD2025-02-07
10194484320758CondorGRAINGER INTERNATIONAL, INC.EWD2024-09-05
EDET033491aquaplus colormix yellow 8 x 50 ml DETAX GmbHEWD2024-08-28
EDET033501aquaplus colormix green8 x 50 ml DETAX GmbHEWD2024-08-28
EDET033541aquaplus colormix orange 8 x 50 ml DETAX GmbHEWD2024-08-28
EDET041661bioflex 40 blue 4x50mlDETAX GmbHEWD2024-08-28
EDET041671bioflex 40 rose 4x50mlDETAX GmbHEWD2024-08-28
EDET041681bioflex 40 red 4x50mlDETAX GmbHEWD2024-08-28
EDET041691bioflex 40 transparent 4x50mlDETAX GmbHEWD2024-08-28
10850015055727ULINE REUSABLE EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-25
10850015055734ULINE REUSABLE EARPLUGS - CORDEDULINE, INC.EWD2024-07-25
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDULINE, INC.EWD2024-07-25
10850015055741ULINE BULLET EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
10850015055758ULINE BULLET EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
10850015055765ULINE BELL EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
10850015055772ULINE BELL EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
30850015055523ULINE BULLET EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
30850015055530ULINE BULLET EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
30850015055547ULINE BELL EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
30850015055554ULINE BELL EARPLUGS - CORDEDULINE, INC.EWD2024-07-23