FDA.reportPublic FDA data

Howard Leight

Primary DI
10033552003714
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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 for insertion 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014982953
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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