Activon Tulle

Basic Information

• Brand Name: Activon Tulle
• Primary DI: 05060031474145
• Version / Model: CR4136
• Company Name: BRIGHTWAKE LIMITED
• Labeler DUNS: 226502201
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-27
• Public Version: 2
• Public Version Date: 2025-07-17
• Public Version Status: Update
• Public Device Record Key: 6e7ca59d-6094-43ee-990b-b6d96757aa42

Device Description

Knitted viscose mesh impregnated with 100% Manuka honey, 10cm x 10cm. Activon Tulle is a knitted viscose mesh primary dressing impregnated with 100% Medical Grade Manuka honey. Activon Tulle creates a moist healing environment and effectively eliminates wound odour. Activon Tulle® is ideally suited to debriding and de-sloughing shallow wounds or where the exudate levels have started to decrease.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
47203	Wound-nonadherent dressing, permeable, antimicrobial	A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060031474152	GS1	Retail	5	In Commercial Distribution
Primary	05060031474145	GS1
Package	05060031474169	GS1	Shipper	56	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101118	000

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter
Width	10	Centimeter