Mepitel® Film

Basic Information

• Brand Name: Mepitel® Film
• Primary DI: 07332551974350
• Version / Model: 296270
• Company Name: Mölnlycke Health Care AB
• Labeler DUNS: 631770658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-21
• Public Version: 2
• Public Version Date: 2022-11-23
• Public Version Status: Update
• Public Device Record Key: 11ba428a-1389-4a3f-818b-9940ea233a14

Device Description

Mepitel Film 10x12cm

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, wound, occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58316	Synthetic polymer semi-permeable film dressing, wound-nonadherent	A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed. It may be applied directly to tissue or used in combination with other dressings (e.g., gels) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, shallow ulcers). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07323190262991	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution
Primary	07332551974350	GS1
Package	07323190262984	GS1	CASE	7	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10cm x 12cm