McKesson

Basic Information

• Brand Name: McKesson
• Primary DI: 10612479268682
• Version / Model: 1726
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Labeler DUNS: 023904428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-28
• Public Version: 1
• Public Version Date: 2023-12-06
• Public Version Status: New
• Public Device Record Key: 1037aaaf-2521-4061-9cb2-ba7778cc19f9

Device Description

Silver Antimicrobial Wound Gel

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
66979	Antiseptic skin gel	A solution in the form of a gel intended to be topically applied to inhibit the growth of microorganisms on the skin to prevent infection (e.g., neonatal umbilical cord infection); it is not intended to treat established skin infections. It includes an antiseptic agent (e.g., chlorohexidine) that functions by a physical mechanism of action. After application it cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20612479269181	GS1	Box	10	In Commercial Distribution
Primary	10612479268682	GS1
Package	40612479268690	GS1	Case	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K110458	000