PureLife+ Digital Sensor Sleeves 1084301

GUDID D79010843010

PureLife+ Digital Sensor Sleeves, Size 2 - 1 5/8" x 8 3/8" , High-quality, clear plastic digital sensor sleeves

PURELIFE, LLC

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• Primary Device ID: D79010843010
• NIH Device Record Key: 610ccac3-58d9-425d-8959-6a3394455bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureLife+ Digital Sensor Sleeves
• Version Model Number: 1084301
• Catalog Number: 1084301
• Company DUNS: 828690904
• Company Name: PURELIFE, LLC
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• 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	D79010843010 [Unit of Use]
HIBCC	D79010843011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190484

FDA Product Code

• NRD: Unit, operative dental, accessories

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