Identity
- Trade Name
- Activon Tulle FDA UDI
- Generic Name
- Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CR4136 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060031474145 FDA UDI
- 510(k) Number
- K101118 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, permeable, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDIWidth — 10 Centimeter FDA UDI
Category: Wound-nonadherent dressing, permeable, antimicrobial
Activon Tulle by Brightwake Limited — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, permeable, antimicrobial.
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Cleared under the same submission
K101118 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Brightwake Limited
Sources (2)
- FDA UDI 6e7ca59d-6094-43ee-990b-b6d96757aa42 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026