Miro3D®

GUDID 00857072005330

Wound Matrix

REPRISE BIOMEDICAL, INC.

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• Primary Device ID: 00857072005330
• NIH Device Record Key: 33431d98-cd71-4d66-b678-81c58e2881d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miro3D®
• Version Model Number: 3010
• Company DUNS: 043611421
• Company Name: REPRISE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com

Device Dimensions

• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Height: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857072005330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221520

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2022-11-29
• Device Publish Date: 2022-11-21

On-Brand Devices [Miro3D®]

• 00857072005347: Wound Matrix
• 00857072005330: Wound Matrix
• 00857072005323: Wound Matrix
• 00857072005316: Wound Matrix