American White Cross

Basic Information

• Brand Name: American White Cross
• Primary DI: 10665973018130
• Version / Model: 7510327 and 7565033 and 7590000
• Catalog Number: 7510327 and 7565033 and 7590000
• 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: 29ee861c-7f40-409a-982d-52aa704d76d9

Device Description

Non Adherent Pad 2" x 3", 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
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30665973018134	GS1	Case	36	In Commercial Distribution
Package	20665973018137	GS1	Box	10	In Commercial Distribution
Primary	10665973018130	GS1
Package	70665973018132	GS1	Case	3600	In Commercial Distribution
Package	40665973018131	GS1	Box	100	In Commercial Distribution
Package	50665973018138	GS1	Case	12	In Commercial Distribution

Customer Contacts

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