Low Speed Handpiece Sleeve

GUDID 20302736704509

YOUNG DENTAL MANUFACTURING I, LLC

Dental bib
Primary Device ID20302736704509
NIH Device Record Key93de25e6-cd83-48ed-ac2b-c2d426217c7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLow Speed Handpiece Sleeve
Version Model Number670450
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
GS110302736704502 [Primary]
GS120302736704509 [Package]
Contains: 10302736704502
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

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