CARDINAL HEALTH ESSENTIALS

Basic Information

• Brand Name: CARDINAL HEALTH ESSENTIALS
• Primary DI: 10885380115981
• Version / Model: ZSHG15
• Catalog Number: ZSHG15
• Company Name: RGH ENTERPRISES
• Labeler DUNS: 049735438
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-23
• Public Version: 2
• Public Version Date: 2021-12-09
• Public Version Status: Update
• Public Device Record Key: ee5e3f41-6d8b-4363-aa42-80380e11610f

Device Description

Silver Amorphous Hydrogel; Silver; 1.575 oz Tube

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00885380115984	GS1	BOX	1	In Commercial Distribution
Primary	10885380115981	GS1
Package	50885380115989	GS1	CASE	40	In Commercial Distribution

Customer Contacts

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