ACTISORB® SILVER 220

Basic Information

• Brand Name: ACTISORB® SILVER 220
• Primary DI: 15051978002734
• Version / Model: 650220
• Catalog Number: 650220
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• Labeler DUNS: 211352227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-24
• Public Version: 3
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 31419b8f-f51c-4e5f-9693-96d408ecc6da

Device Description

Antimicrobial Binding 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: 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: 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
47475	Odour-absorbent dressing, antimicrobial	A pad covering for malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours typically through a layer of activated charcoal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. Given the types of wounds to which it is typically applied, the device may also contain a layer that absorbs heavy exudates, and one that minimizes adherence to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25051978002731	GS1		10	In Commercial Distribution
Primary	15051978002734	GS1

Device Sizes

Type	Value	Unit	Text
Width	6.5	Centimeter
Length	9.5	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature