American White Cross

Basic Information

• Brand Name: American White Cross
• Primary DI: 10665973018017
• Version / Model: 7205327 and 7206327 and 7260033
• Catalog Number: 7205327 and 7206327 and 7260033
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 1d7e55f5-a970-4174-bfcf-2f4bf8f3098c

Device Description

Non-Woven Pad 2" x 2" 4-Ply, Sterile

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	20665973018014	GS1	Box	10	In Commercial Distribution
Primary	10665973018017	GS1
Package	70665973018019	GS1	Case	12	In Commercial Distribution
Package	60665973018012	GS1	Box	100	In Commercial Distribution
Package	50665973018015	GS1	Case	24	In Commercial Distribution
Package	40665973018018	GS1	Box	25	In Commercial Distribution
Package	30665973018011	GS1	Case	36	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]