Anthem Wound Matrix Fenestrated

Basic Information

• Brand Name: Anthem Wound Matrix Fenestrated
• Primary DI: 00852513007256
• Version / Model: FG-0033
• Catalog Number: AN-0033
• Company Name: NANOFIBER SOLUTIONS, INC.
• Labeler DUNS: 830384223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 2
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: e95135aa-12ad-4e63-b75b-5590c21724bc

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
62184	Synthetic nanofiber barrier dressing	A sterile covering made of porous, non-woven, synthetic nanofiber material intended to provide protection and/or promote healing of acute and chronic skin wounds. It is a thin, synthetic polymer (e.g., polycaprolactone) fabric material intended to adhere to the wound (without adhesive) to form a barrier against contamination (e.g., from dirt, water, bacteria) while allowing air to contact the wound; it may be semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) and provides minimal wound exudate absorbency. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852513007256	GS1