LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295102833
• Version / Model: 2256881
• Catalog Number: 2256881
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-18
• Public Version: 3
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: 3ff2b748-0e14-44c2-8519-c8427362c992

Device Description

Rolled Gauze for Securing a Dressing; Protects and Cushions; Latex Free; 1 Sterile Roll; Unstretched; 3 IN. x 2.5 YDS

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
63661	Non-woven gauze roll/sheet	A device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295102838	GS1	CASE	24	In Commercial Distribution
Primary	00096295102833	GS1

Customer Contacts

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