Mack's 200

GUDID 10033732002001

Moldable Silicone Earplugs - 200-pair Dispenser

McKeon Products, Inc.

Earplugs, reusable
Primary Device ID10033732002001
NIH Device Record Key2267d977-f6cf-4415-b644-a6dc6e3d9e5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMack's
Version Model NumberPillow Soft Silicone Putty Earplug Dispenser
Catalog Number200
Company DUNS006522122
Company NameMcKeon Products, Inc.
Device Count400
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
GS100033732002004 [Primary]
GS110033732002001 [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