CVS Health

Basic Information

• Brand Name: CVS Health
• Primary DI: 00050428341568
• Version / Model: 894101
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• Labeler DUNS: 062312574
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 4
• Public Version Date: 2021-09-15
• Public Version Status: Update
• Public Device Record Key: a4aa4f63-83e6-4bb2-a988-c532d5c09985
• Distribution End Date: 2021-07-30

Device Description

Sterile Gauze Pads, 12-ply design, 2 IN x 2 IN (5 cm x 5 cm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20050428341562	GS1	case	36	Not in Commercial Distribution	2021-07-30
Primary	00050428341568	GS1
Unit of Use	60050428341560	GS1

Customer Contacts

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