PureHorizon 1067305

GUDID D79010673053

X-Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material

PURELIFE, LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD79010673053
NIH Device Record Key2e8278b2-e5f2-4f45-a8ad-4947ddac3802
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureHorizon
Version Model Number1067305
Catalog Number1067305
Company DUNS828690904
Company NamePURELIFE, LLC
Device Count200
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com
Phone877-777-3303
EmailSales@PureLifeDental.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79010673050 [Unit of Use]
HIBCCD79010673051 [Primary]
HIBCCD79010673053 [Package]
Contains: D79010673051
Package: Case [2000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-04-05
Device Publish Date2021-03-26

On-Brand Devices [PureHorizon]

D79010673053X-Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains rec
D79010673043Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recyc
D79010673033Medium, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recy
D79010673023Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recyc
D79010673013X-Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains rec
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