FDA.reportPublic FDA data

Mack's

Primary DI
00033732002103
Brand
Mack's
Company
McKeon Products, Inc.
Model
Kids Size Moldable Silicone Putty Earplug Dispense
Catalog number
210
Device description
Kids Size Soft Moldable Silicone Earplugs - 200-pair Dispenser
Published
2022-10-07
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
EWDProtector, Hearing (Insert)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00033732002103PrimaryGS10
10033732002100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00033732002103000337320021030337320021030033732002103
1003373200210010033732002100

GMDN Terms#

Term, Definition table
TermDefinition
Earplugs, reusableA 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 reusable device.

Regulatory Flags#

DUNS number
006522122
Device count
400
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00033732000789Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732007122Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732007184Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
00033732100786Mack'sPillow Soft Silicone Putty Earplugs7T2025-08-05
00033732107129Mack'sPillow Soft Silicone Putty Earplugs7122025-08-05
00033732107181Mack'sPillow Soft Silicone Putty Earplugs7182025-08-05
00033732000055Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
00033732000062Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
00033732000086Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
00033732000109Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07
00033732002004Mack'sPillow Soft Silicone Putty Earplug Dispenser2002022-10-07
00033732002066Mack'sPillow Soft Silicone Putty Earplug Dispenser (Oran2062022-10-07
00033732002080Mack'sPillow Soft Silicone Putty Earplug Dispenser (Beig2082022-10-07
00033732010153Mack'sKids Size Soft Moldable Silicone Putty Earplugs10152022-10-07
10033732000052Mack'sPillow Soft Silicone Putty Earplugs52022-10-07
10033732000069Mack'sPillow Soft Silicone Putty Earplugs (Orange)62022-10-07
00033732000079Mack'sPillow Soft Silicone Putty Earplugs72022-10-07
10033732000083Mack'sPillow Soft Silicone Putty Earplugs (Beige)82022-10-07
10033732000106Mack'sKids Size Soft Moldable Silicone Putty Earplugs102022-10-07
10033732002001Mack'sPillow Soft Silicone Putty Earplug Dispenser2002022-10-07

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