Mack's 206

GUDID 10033732002063

Moldable Silicone Earplugs (Orange) - 200-pair Dispenser

McKeon Products, Inc.

Earplugs, reusable
Primary Device ID10033732002063
NIH Device Record Keye3f51196-712b-4c86-81cc-bb10645de6bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMack's
Version Model NumberPillow Soft Silicone Putty Earplug Dispenser (Oran
Catalog Number206
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
GS100033732002066 [Primary]
GS110033732002063 [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