PureOrtho 1068501

GUDID D79010685013

PureOrtho Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Tiffany 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 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 IDD79010685013
NIH Device Record Key8290422e-28ae-4358-ad8d-2cdb20ec1102
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureOrtho
Version Model Number1068501
Catalog Number1068501
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 Latexfalse
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
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
Phone+1(877)777-3303
Emailsales@purelifedental.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment, avoid direct sunlight, avoid fluorescent lighting, avoid heat and moisture

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79010685010 [Unit of Use]
HIBCCD79010685011 [Primary]
HIBCCD79010685013 [Package]
Contains: D79010685011
Package: Case [1000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZCPatient examination glove, specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-24
Device Publish Date2022-11-16

On-Brand Devices [PureOrtho]

D79010685053PureOrtho Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Tiffany blue in color, Packa
D79010685043PureOrtho Nitrile Powder-Free, Large, Nitrile powder-free gloves, Tiffany blue in color, Packagi
D79010685033PureOrtho Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Tiffany blue in color, Packag
D79010685023PureOrtho Nitrile Powder-Free, Small, Nitrile powder-free gloves, Tiffany blue in color, Packagi
D79010685013PureOrtho Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Tiffany blue in color, Packa
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.