Identity
- Trade Name
- Avance® Solo FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Avance Solo Foam FDA UDI
- Model / Reference
- 882000 FDA UDI
- Description
- Avance Solo Foam FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07323190244683 FDA UDI
- 510(k) Number
- K203369 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial 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
No
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
MR Safe FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Avance® Solo by Mölnlycke Health Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
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- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
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- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
Cleared under the same submission
K203369 also covers:
- Avance® — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
- Avance® Solo — Mölnlycke Health Care AB
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
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI 2441f221-25fe-49a4-909a-d9b72c415932 35 fields · synced May 30, 2026