ACTICOAT FLEX7 4" X 5"

Basic Information

• Brand Name: ACTICOAT FLEX7 4" X 5"
• Primary DI: 00040565124339
• Version / Model: 66800405
• Catalog Number: 66800405
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-18
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 8f534e78-b5a6-4482-9dcb-8d17b73981d6

Device Description

Silver-coated antimicrobial barrier dressing

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	00040565124483	GS1	Carton	5	In Commercial Distribution
Primary	00040565124339	GS1
Package	30040565124484	GS1	Case	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K083113	000