Mack's 718

GUDID 00033732107181

Moldable Silicone Earplugs - 18 Pair Box

McKeon Products, Inc.

Earplugs, reusable
Primary Device ID00033732107181
NIH Device Record Keyc15f89c8-aa81-47bb-8154-2c7840a98f36
Commercial Distribution StatusIn Commercial Distribution
Brand NameMack's
Version Model NumberPillow Soft Silicone Putty Earplugs
Catalog Number718
Company DUNS006522122
Company NameMcKeon Products, Inc.
Device Count36
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100033732007184 [Primary]
GS100033732107181 [Unit of Use]

FDA Product Code

EWDProtector, Hearing (Insert)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-13
Device Publish Date2025-08-05