Mirragen Advanced Wound Matrix MWM-075-075EA

GUDID 00812005030537

Mirragen, 7.5 cm x 7.5 cm, single boxed pouch

ETS Wound Care LLC

Synthetic wound matrix dressing

• Primary Device ID: 00812005030537
• NIH Device Record Key: 660b9b3a-1cf6-4bf0-b6b9-ecf575d04c0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mirragen Advanced Wound Matrix
• Version Model Number: 7.5 cm x 7.5 cm
• Catalog Number: MWM-075-075EA
• Company DUNS: 080578874
• Company Name: ETS Wound Care LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812005030537 [Primary]

FDA Product Code

• QSZ: Absorbable Synthetic Wound Dressing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-11
• Device Publish Date: 2026-03-03

Devices Manufactured by ETS Wound Care LLC

• 00812005030537 - Mirragen Advanced Wound Matrix: 2026-03-11Mirragen, 7.5 cm x 7.5 cm, single boxed pouch
• 00812005030537 - Mirragen Advanced Wound Matrix: 2026-03-11 Mirragen, 7.5 cm x 7.5 cm, single boxed pouch
• 00812005030421 - MIRRASURG™: 2024-10-03 Resorbable Borate Glass Wound Management Device
• 00812005030438 - MIRRAGEN® Advanced Wound Matrix: 2024-10-03 Resorbable Borate Glass Wound Management Device
• 00812005030407 - MIRRAGEN® Advanced Wound Matrix: 2024-03-14 "Resorbable Borate Glass Wound Management Device"
• 00812005030254 - MIRRAGEN® Advanced Wound Matrix: 2023-08-08 Resorbable Borate Glass Wound Management Device
• 00812005030377 - MIRRAGEN® Advanced Wound Matrix: 2023-08-08 Resorbable Borate Glass Wound Management Device
• 00812005030230 - MIRRAGEN® Advanced Wound Matrix: 2023-02-09 Resorbable Borate Glass Wound Management Device
• 00812005030292 - MIRRAGEN® Advanced Wound Matrix: 2023-02-09 Resorbable Borate Glass Wound Management Device