PureLife+ Cotton Rolls

Basic Information

• Brand Name: PureLife+ Cotton Rolls
• Primary DI: D79011131011
• Version / Model: 1113101
• Catalog Number: 1113101
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2000
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: adcee6f4-2200-4efc-a147-5e0ca900efa5

Device Description

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")

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFN	COTTON, ROLL	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D79011131010	HIBCC
Primary	D79011131011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]