Avance®

Basic Information

• Brand Name: Avance®
• Primary DI: 07332551876944
• Version / Model: 662000
• Company Name: Mölnlycke Health Care AB
• Labeler DUNS: 631770658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-27
• Public Version: 1
• Public Version Date: 2021-02-04
• Public Version Status: New
• Public Device Record Key: 310690e4-e55b-434d-bb62-1c1477073432

Device Description

Avance transparent film 20x28cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	negative pressure wound therapy Powered suction pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47405	Negative-pressure wound therapy system drape	A sheet of plastic material designed to be placed over a wound dressing (e.g. open-cell foam or medicated gauze) to create a complete occlusion over and around a wound during negative pressure wound therapy (NPWT). This film dressing is typically vapour permeable, waterproof, and has an adhesive backing or edges applied against the wound dressing and surrounding healthy skin to create an airtight seal; it may be impregnated/coated with a gel (e.g., silicone) to minimize risk of trauma upon removal. It has a central opening, or an opening is made in or under it, to enable placement of the drain allowing negative pressure to reach the wound through the dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07323190023226	GS1		6	In Commercial Distribution
Package	07323190023233	GS1		5	In Commercial Distribution
Primary	07332551876944	GS1
Package	07323190193783	GS1		5	Not in Commercial Distribution	1995-12-31
Package	07323190193776	GS1		6	Not in Commercial Distribution	1995-12-31

Premarket Submissions

Submission Number	Supplement Number
K122132	000

Device Sizes

Type	Value	Unit	Text
Width	0.0	Millimeter
Height	0.0	Millimeter
Length	0.0	Millimeter