FDA.reportPublic FDA data

Activon Tulle

Primary DI
05060031474152
Brand
Activon Tulle
Company
BRIGHTWAKE LIMITED
Model
CR4136
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.
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
05060031474152PackageGS15In Commercial Distribution
05060031474169PackageGS156In Commercial Distribution
05060031474145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060031474152050600314741525060031474152
05060031474169050600314741695060031474169
05060031474145050600314741455060031474145

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
Length10Centimeter
Width10Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
226502201
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05060031474107Activon TulleCR41352024-01-18
05060031479676Eclypse ContourCR43982023-07-27
05060031471182Activon TubeCR38302023-07-27
05060031482003Activon TubeCR44932023-07-27
05060031475708Advazorb Border CR41952024-01-17
05060031475715Advazorb Border CR41952024-01-17

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