Mack's 1015

GUDID 10033732010150

Kids Size Silicone Earplugs - 15 pair box - Orange

McKeon Products, Inc.

Earplugs, reusable
Primary Device ID10033732010150
NIH Device Record Keye44386ed-fff4-4b51-a516-170419c7a58a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMack's
Version Model NumberKids Size Soft Moldable Silicone Putty Earplugs
Catalog Number1015
Company DUNS006522122
Company NameMcKeon Products, Inc.
Device Count30
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
GS100033732010153 [Primary]
GS110033732010150 [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 Date2022-10-17
Device Publish Date2022-10-07