MIRRAGEN® Advanced Wound Matrix

GUDID 00812005030407

"Resorbable Borate Glass Wound Management Device"

ETS WOUND CARE LLC

Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial Cavity-wound management dressing, non-antimicrobial

• Primary Device ID: 00812005030407
• NIH Device Record Key: bcd092b9-059b-4c48-b667-743087674a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRRAGEN® Advanced Wound Matrix
• Version Model Number: MWM-035-035
• Company DUNS: 080578874
• Company Name: ETS WOUND CARE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com
• Phone: 573-202-2550
• Email: support@etswoundcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812005030391 [Primary]
GS1	00812005030407 [Package]; Contains: 00812005030391; Package: Box [10 Units]; In Commercial Distribution

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: 2024-03-14
• Device Publish Date: 2024-03-06

On-Brand Devices [MIRRAGEN® Advanced Wound Matrix]

• 00812005030117: Resorbable Borate Glass Wound Management Device
• 00812005030056: Resorbable Borate Glass Wound Management Device
• B477MWM0404SB1: Resorbable Borate Glass Wound Management Device
• B477MWM0202SB1: Resorbable Borate Glass Wound Management Device
• B477MWM0106SB1: Resorbable Borate Glass Wound Management Device
• 00812005030292: Resorbable Borate Glass Wound Management Device
• 00812005030230: Resorbable Borate Glass Wound Management Device
• 00812005030377: Resorbable Borate Glass Wound Management Device
• 00812005030254: Resorbable Borate Glass Wound Management Device
• 00812005030407: "Resorbable Borate Glass Wound Management Device"