MIRRASURG™

GUDID 00812005030339

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

• Primary Device ID: 00812005030339
• NIH Device Record Key: e346b7be-f8a5-4d27-9e1f-e9d6fe48d000
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRRASURG™
• Version Model Number: MSG-0106
• 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
• 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	00812005030322 [Primary]
GS1	00812005030339 [Package]; Contains: 00812005030322; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161067

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [MIRRASURG™]

• 00812005030339: Resorbable Borate Glass Wound Management Device
• 00812005030346: Resorbable Borate Glass Wound Management Device