Identity
- Trade Name
- Avance® FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, single-use FDA UDI
- Device Name
- Avance Solo Carrier Case FDA UDI
- Model / Reference
- 890003 FDA UDI
- Description
- Avance Solo Carrier Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07333350965044 FDA UDI
- 510(k) Number
- K203369 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, single-use 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 Unsafe FDA UDI
Category: Negative-pressure wound therapy system, electric, single-use
Avance® by Mölnlycke Health Care AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203369 also covers:
- 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
- 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 |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI d89b15f3-ceda-4b06-b99f-91d1f83e459d 36 fields · synced May 30, 2026