PureOnyx 1068104

GUDID D79010681040

PureOnyx Black Nitrile Powder-Free, Large, Nitrile powder-free gloves, Textured fingertips, Black in color, Packaging contains recycled material

PURELIFE, LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD79010681040
NIH Device Record Key9db994fd-5209-454a-b4d7-2fd2759bde35
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureOnyx
Version Model Number1068104
Catalog Number1068104
Company DUNS828690904
Company NamePURELIFE, LLC
Device Count100
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com
Phone+1(877)777-3303
Emailsales@purelifedental.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79010681040 [Unit of Use]
HIBCCD79010681041 [Primary]

FDA Product Code

LZAPolymer patient examination glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-02
Device Publish Date2023-09-22

On-Brand Devices [PureOnyx]

D79010681050PureOnyx Black Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Textured fingertips, Bl
D79010681040PureOnyx Black Nitrile Powder-Free, Large, Nitrile powder-free gloves, Textured fingertips, Blac
D79010681030PureOnyx Black Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Textured fingertips, Bla
D79010681020PureOnyx Black Nitrile Powder-Free, Small, Nitrile powder-free gloves, Textured fingertips, Blac
D79010681010PureOnyx Black Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Textured fingertips, Bl

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