LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295141160
• Version / Model: 5736384
• Catalog Number: 5736384
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2022-01-06
• Public Version: 1
• Public Version Date: 2022-01-14
• Public Version Status: New
• Public Device Record Key: ec007a0a-b1c5-41f7-8f30-cb45cb6a6cb6

Device Description

LDR Sterile Transparent Waterseal Dressing 2.375in x 2.75in 8 ea

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: 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
58302	Antimicrobial synthetic polymer semi-permeable film dressing, adhesive	A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent. It is a thin, clear film made of synthetic polymer with a pressure-sensitive adhesive on one side that may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions, ulcers, burns, lacerations, abrasions, device insertion sites, and donor/graft sites. It may also be used to secure to skin other devices (e.g., catheters, drains, leads, ports). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295141165	GS1	CASE	24	In Commercial Distribution
Primary	00096295141160	GS1
Unit of Use	10096295141167	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2.375	Inch
Length	2.75	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius