Short Pen Sleeve

GUDID 20302736702505

YOUNG DENTAL MANUFACTURING I, LLC

Dental bib
Primary Device ID20302736702505
NIH Device Record Keycdf54049-4067-43fb-b6b3-cc82f7fdd804
Commercial Distribution StatusIn Commercial Distribution
Brand NameShort Pen Sleeve
Version Model Number670250
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110302736702508 [Primary]
GS120302736702505 [Package]
Contains: 10302736702508
Package: Box [500 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEMDental Barriers And Sleeves

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-10
Device Publish Date2017-10-27

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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