Identity
- Trade Name
- Avance FDA UDI
- Generic Name
- Negative-pressure wound therapy system dressing set FDA UDI
- Model / Reference
- 662152-01 FDA UDI
Identifiers
- Catalog Number
- 662152 FDA UDI
- Primary DI / UDI-DI
- 07323190047109 FDA UDI
- 510(k) Number
- K161797 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 dressing set
Avance 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 dressing set.
- 3M™ Snap™ — KCI USA, INC. · Class II
- Advanced Series Hydrophobic Dressing Kit, Medium — Pensar Medical, LLC · Class II
- Nisus NPWT Wound Kit — Cork Medical · Class II
- 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
- AVELLE — CONVATEC, PURCHASING DEPARTMENT · Class II
Cleared under the same submission
K161797 also covers:
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — Mölnlycke Health Care AB
- Avance — 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 24c1d0c3-c7b8-46f4-b264-779cdbd09760 34 fields · synced May 30, 2026