Mack's 712

GUDID 00033732107129

Moldable Silicone Earplugs - 12 Pair Box

McKeon Products, Inc.

Earplugs, reusable
Primary Device ID00033732107129
NIH Device Record Key3f5adcbd-d5a4-4c72-b7de-12ff521a2c4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMack's
Version Model NumberPillow Soft Silicone Putty Earplugs
Catalog Number712
Company DUNS006522122
Company NameMcKeon Products, Inc.
Device Count24
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
GS100033732007122 [Primary]
GS100033732107129 [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