PureLife Dental 1110302

GUDID D79011103020

4" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting

PURELIFE, LLC

Non-woven gauze pad, non-sterile Non-woven gauze pad, non-sterile Non-woven gauze pad, non-sterile Non-woven gauze pad, non-sterile
Primary Device IDD79011103020
NIH Device Record Key5a4abaf2-7dcc-431e-b60a-0cd5552e8ec6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureLife Dental
Version Model Number1110302
Catalog Number1110302
Company DUNS828690904
Company NamePURELIFE, LLC
Device Count2000
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79011103020 [Unit of Use]
HIBCCD79011103020 [Unit of Use]
HIBCCD79011103020 [Unit of Use]
HIBCCD79011103020 [Unit of Use]
HIBCCD79011103021 [Primary]
HIBCCD79011103021 [Primary]
HIBCCD79011103021 [Primary]
HIBCCD79011103021 [Primary]

FDA Product Code

NACDressing, Wound, Hydrophilic
NACDressing, Wound, Hydrophilic
NACDressing, Wound, Hydrophilic
NACDressing, Wound, Hydrophilic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

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

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