MIRRAGEN® Advanced Wound Matrix

Basic Information

• Brand Name: MIRRAGEN® Advanced Wound Matrix
• Primary DI: 00812005030391
• Version / Model: MWM-045-045
• Company Name: ETS Wound Care LLC
• Labeler DUNS: 080578874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-06
• Public Version: 4
• Public Version Date: 2025-02-03
• Public Version Status: Update
• Public Device Record Key: bcd092b9-059b-4c48-b667-743087674a8a

Device Description

"Resorbable Borate Glass Wound Management Device"

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
QSZ	Absorbable Synthetic Wound Dressing	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64853	Synthetic wound matrix dressing	A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00812005030407	GS1	Box	10	In Commercial Distribution
Primary	00812005030391	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161067	000