Howard Leight by Honeywell R-02236

GUDID 00033552022367

TRUSTFIT POD Uncorded Multiple-Use Earplugs

SPERIAN HEARING PROTECTION, LLC

Earplugs, single-use
Primary Device ID00033552022367
NIH Device Record Key833cd778-0723-4e4a-bc7a-324ddf6a5e65
Commercial Distribution StatusIn Commercial Distribution
Brand NameHoward Leight by Honeywell
Version Model NumberTRUSTFIT
Catalog NumberR-02236
Company DUNS014982953
Company NameSPERIAN HEARING PROTECTION, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100033552022367 [Primary]

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 Date2020-09-21
Device Publish Date2020-09-11

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