Identity
- Trade Name
- AVELLE FDA UDI
- Generic Name
- Negative-pressure wound therapy system dressing set FDA UDI
- Device Name
- Avelle™ Negative Pressure Wound Therapy Dressing 12X31Cm FDA UDI
- Model / Reference
- 421555 FDA UDI
- Description
- Avelle™ Negative Pressure Wound Therapy Dressing 12X31Cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455139286 FDA UDI
- 510(k) Number
- K180205 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system dressing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
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
- Width — 12 Centimeter FDA UDILength — 31 Centimeter FDA UDI
Category: Negative-pressure wound therapy system dressing set
Avelle by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system dressing set.
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- 4L — 4L Health Co., Ltd. · Class II
- Kendall — Cardinal Health 200, LLC · Class II
- Advanced Series Combo Pack, Medium — Pensar Medical, LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Cleared under the same submission
K180205 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 90333b4e-3b82-4d29-a6d3-fcbba1afe875 36 fields · synced Jun 6, 2026