FDA UDI
In Commercial Distribution
🇺🇸 United States
Activon Tube
DI: 05060031471182
·
Model: CR3830
·
BRIGHTWAKE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Activon Tube
- Primary DI
- 05060031471182
- Version / Model
- CR3830
- 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
- 2024-10-09
- Public Version Status
- Update
- Public Device Record Key
- a58ce630-174a-47b2-8ad5-d3a1865c2440
Device Description
100% Medical Grade Manuka honey. Activon Tube contains 100% Medical Grade Manuka honey with no additives. This wound filler will eliminate odors and provides a moist wound healing environment that facilitates autolytic debridement. Activon Tube can be used as a wound filler for use in cavities.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 47773 | Medical honey liquid barrier dressing | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060031471199 | GS1 | Dispenser | 12 | In Commercial Distribution | |
| Primary | 05060031471182 | GS1 | ||||
| Package | 05060031471205 | GS1 | Shipper | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +441623751500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101114 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 25 | Gram |