Zooby Face Masks

GUDID 20302732954045

YOUNG DENTAL MANUFACTURING I, LLC

Surgical/medical face mask, single-use
Primary Device ID20302732954045
NIH Device Record Keybe18ba13-660a-4471-b106-549954ce2091
Commercial Distribution StatusIn Commercial Distribution
Brand NameZooby Face Masks
Version Model Number295404
Company DUNS006309355
Company NameYOUNG DENTAL MANUFACTURING I, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110302732954048 [Primary]
GS120302732954045 [Package]
Contains: 10302732954048
Package: shipping box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSHRespirator,Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2017-03-16

Devices Manufactured by YOUNG DENTAL MANUFACTURING I, LLC

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20302732311022 - Young Dental2025-02-25 TRACE DISCLOSING SOL. 2OZ.
20302732322004 - Young Dental2025-02-25 TRACE-28 DISC TAB BULK PK
10302732322106 - Young Dental2025-02-25 TRACE TABLETS 1000 PK
10302732322250 - Young Dental2025-02-25 TRACE DISCL TABLET 250 COUNT
10302732330040 - Young Dental2025-02-25 2 TONE SOLUTION 4 GALLON
00302732331026 - Young Dental2025-02-25 2 TONE DISCLOSING SOL 2 OZ
20302732342002 - Young Dental2025-02-25 2-TONE DISC TAB BULK

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