Avance®

FDA UDI

Class II (US FDA UDI)

by Mölnlycke Health Care AB

Identity

Trade Name: Avance® FDA UDI
Generic Name: Negative-pressure wound therapy system drape FDA UDI
Device Name: Avance transparent film 20x28cm FDA UDI
Model / Reference: 662000 FDA UDI
Description: Avance transparent film 20x28cm FDA UDI

Identifiers

Primary DI / UDI-DI: 07332551876944 FDA UDI
510(k) Number: K122132 FDA UDI
FDA Product Code: OMP FDA UDI
GMDN Term: Negative-pressure wound therapy system drape 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Width — 0.0 Millimeter FDA UDI
Height — 0.0 Millimeter FDA UDI
Length — 0.0 Millimeter FDA UDI

Category: Negative-pressure wound therapy system drape

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 drape.

ExtriCARE — Alleva Medical, Ltd. · Class II
MicroDoc Mini Stingray and Drape Set — Pensar Medical, LLC · Class II
V.A.C.® — KCI USA, INC. · Class II
WoundPro Outer Drape — Pensar Medical, LLC · Class II
V.A.C. DERMATAC™ — KCI USA, INC. · Class II
WoundPro Outer Drape, — Pensar Medical, LLC · Class II
XLR8 Transparent Film Dressing — GENADYNE BIOTECHNOLOGIES, INC. · Class II
V.A.C.® — KCI USA, INC. · Class II

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 310690e4-e55b-434d-bb62-1c1477073432 35 fields · synced May 30, 2026