PureLife+ Cotton Rolls 1113101

GUDID D79011131010

PureLife+ Cotton Rolls, #2 Medium, Non-sterile, soft cotton rolls, Made from 100% cotton; no cellulose or rayon fibers and lint-free, Absorb up to 10 times their weight and maintains their shape when wet, #2 Medium (3/8" x 1 1/2")

PURELIFE, LLC

Dental cotton roll

• Primary Device ID: D79011131010
• NIH Device Record Key: adcee6f4-2200-4efc-a147-5e0ca900efa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureLife+ Cotton Rolls
• Version Model Number: 1113101
• Catalog Number: 1113101
• Company DUNS: 828690904
• Company Name: PURELIFE, LLC
• Device Count: 2000
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com
• Phone: +1(877)777-3303
• Email: sales@purelifedental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D79011131010 [Unit of Use]
HIBCC	D79011131011 [Primary]

FDA Product Code

• EFN: COTTON, ROLL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by PURELIFE, LLC

• D79010201010 - PureSkin: 2023-10-02 PureSkin Latex Powder-Free, X-Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
• D79010201020 - PureSkin: 2023-10-02 PureSkin Latex Powder-Free, Small, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
• D79010201030 - PureSkin: 2023-10-02 PureSkin Latex Powder-Free, Medium, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
• D79010201040 - PureSkin: 2023-10-02 PureSkin Latex Powder-Free, Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
• D79010201050 - PureSkin: 2023-10-02 PureSkin Latex Powder-Free, X-Large, Fully-textured, Polymer-coated, Packaging contains at least 70% recycled material
• D79010217010 - PureBliss: 2023-10-02 PureBliss Latex Powder-Free, X-Small, PureLife donates a portion of the proceeds from the sale of this glove to health and envir
• D79010217020 - PureBliss: 2023-10-02 PureBliss Latex Powder-Free, Small, PureLife donates a portion of the proceeds from the sale of this glove to health and environ
• D79010217030 - PureBliss: 2023-10-02 PureBliss Latex Powder-Free, Medium, PureLife donates a portion of the proceeds from the sale of this glove to health and enviro