PureLife Dental

Basic Information

• Brand Name: PureLife Dental
• Primary DI: D79011103021
• Version / Model: 1110302
• Catalog Number: 1110302
• Company Name: PURELIFE, LLC
• Labeler DUNS: 828690904
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2020-05-13
• Public Version: 2
• Public Version Date: 2020-06-11
• Public Version Status: Update
• Public Device Record Key: 5a4abaf2-7dcc-431e-b60a-0cd5552e8ec6

Device Description

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

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48130	Non-woven gauze pad, non-sterile	A non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon, polyester, cellulose pulp) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D79011103020	HIBCC
Primary	D79011103021	HIBCC
Package	D79011103023	HIBCC	Case	2000	In Commercial Distribution

Customer Contacts

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