Universal Air/Water Syringe Sleeve

GUDID 10302736700504

YOUNG DENTAL MANUFACTURING I, LLC

Dental bib
Primary Device ID10302736700504
NIH Device Record Key71424df3-03cd-41ce-ad37-f5ea52de54fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Air/Water Syringe Sleeve
Version Model Number670050
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
GS110302736700504 [Primary]
GS120302736700501 [Package]
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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10816577024625 - Denticator2024-10-08 Denticator Light Handle Sleeve, Infection Control Barrier
10816577024632 - Denticator2024-10-08 Denticator Low Speed Handpiece Sleeve, Infection Control Barrier
10302730003243 - Young Dental2024-10-07 Cup, Purple, Web, Petite, Soft, LF, Latch, 144ct SAMPLE
10302730003250 - Young Dental2024-10-07 Cup, Young Brands, Purple, Web, Long, Soft, LF, Latch, 144ct SAMPLE

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