FDA.reportPublic FDA data

Activon Tulle

Primary DI
05060031474107
Brand
Activon Tulle
Company
BRIGHTWAKE LIMITED
Model
CR4135
Device description
Knitted viscose mesh impregnated with 100% Manuka honey, 5cm x 5cm. 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.
Published
2024-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101118000ACTIVON TULLECalidad Solutions, Inc.2010-12-15FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060031474114PackageGS15In Commercial Distribution
05060031474121PackageGS156In Commercial Distribution
05060031474107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060031474114050600314741145060031474114
05060031474121050600314741215060031474121
05060031474107050600314741075060031474107

GMDN Terms#

Term, Definition table
TermDefinition
Medical honey liquid barrier dressingA material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Centimeter
Width5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441623751500info@advancis.co.uk

Regulatory Flags#

DUNS number
226502201
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060031485424Tracoe Purofoam-T LargeCR45552025-10-08
05060031485462Tracoe Purofoam-T Large LiteCR45562025-10-08
05060031485509Tracoe Purofoam-T SmallCR45572025-10-08
05060031482645Eclypse Non-BackedCR45172025-08-07
05060031482683Eclypse Non-BackedCR45182025-08-07
05060031482720Eclypse Non-BackedCR45192025-08-07
05060031484724Activon Manuka Honey Barrier CreamCR45462025-08-07
05060031482652Eclypse Non-BackedCR45172025-08-07
05060031482690Eclypse Non-BackedCR45182025-08-07
05060031482737Eclypse Non-BackedCR45192025-08-07
05060031484748Activon Manuka Honey Barrier CreamCR45462025-08-07
05060031485349Activon Manuka Honey Barrier CreamCR45522025-08-07
05060031482607Eclypse Non-BackedCR45162025-08-05
05060031474145Activon TulleCR41362023-07-27
05060031479676Eclypse ContourCR43982023-07-27
05060031471182Activon TubeCR38302023-07-27
05060031482003Activon TubeCR44932023-07-27
05060031475708Advazorb Border CR41952024-01-17
05060031475715Advazorb Border CR41952024-01-17
05060031470901EclypseCR37692023-07-27

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