PureLife Dental 1190101

GUDID D79011901013

2 1/4" x 4" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink

PURELIFE, LLC

Sterilization packaging, single-use Sterilization packaging, single-use
Primary Device IDD79011901013
NIH Device Record Key55072d44-4da4-4b1e-b782-169b3bea13df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureLife Dental
Version Model Number1190101
Catalog Number1190101
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 Batchtrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79011901010 [Unit of Use]
HIBCCD79011901011 [Primary]
HIBCCD79011901013 [Package]
Contains: D79011901011
Package: Case [20000 Units]
In Commercial Distribution

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-24
Device Publish Date2017-03-17

On-Brand Devices [PureLife Dental]

D790119010535 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indica
D790119010433 1/2" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat
D790119010333 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process ind
D790119010232 3/4" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat
D790119010132 1/4" x 4" Sterilization Pouches, Built-in color-changing internal and external process indicat
D79011501023Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex
D79011501013Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex
D790111030204" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
D790111030102" x 2" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
D79010811040Lilac "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79010811030Pink "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79010811020Blue "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79010811010White "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock
D79011549023PureLife Level 3 Masks Pink
D79011549013PureLife Level 3 Masks Blue
D79011430023Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comf
D79011430013White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient com

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