ACTICOAT FLEX

Basic Information

• Brand Name: ACTICOAT FLEX
• Primary DI: 05000223502218
• Version / Model: 66027684
• Catalog Number: 66027684
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-26
• Public Version: 1
• Public Version Date: 2026-04-03
• Public Version Status: New
• Public Device Record Key: d23d6a22-6fb9-4dbf-b1bf-16abbaa8fe7f

Device Description

ACTICOAT FLEX 2"x2" CTN 5 US

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: No
• MRI Safety: MR Unsafe
• 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: Yes
• 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
47042	Wound-nonadherent dressing, absorbent, antimicrobial	A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05000223502232	GS1	CAS	20	In Commercial Distribution
Package	05000223502225	GS1	CAR	5	In Commercial Distribution
Primary	05000223502218	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083113	000

Device Sizes

Type	Value	Unit	Text
Length	2	Inch
Width	2	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: 25 C
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight