Mepilex® Border Lite

Basic Information

• Brand Name: Mepilex® Border Lite
• Primary DI: 07323190127092
• Version / Model: 281388
• Company Name: Mölnlycke Health Care AB
• Labeler DUNS: 631770658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-28
• Public Version: 2
• Public Version Date: 2021-02-01
• Public Version Status: Update
• Public Device Record Key: ee242d18-a9f4-44d7-a68c-760a617d1f93

Device Description

Mepilex Border Lite 4x4in/10x10cm, CVS

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAC	Dressing, wound, hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn 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	00050428280263	GS1		3	Not in Commercial Distribution	1995-12-31
Primary	07323190127092	GS1
Package	07323190105106	GS1		10	Not in Commercial Distribution	1995-12-31

Device Sizes

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 35 Degrees Celsius