Miro3D® Fibers

GUDID 00857072005422

Wound matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00857072005422
• NIH Device Record Key: 07682a25-ffc6-428e-9006-be533f3c4f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miro3D® Fibers
• Version Model Number: 4005
• Company DUNS: 043611421
• Company Name: REPRISE BIOMEDICAL, INC.
• 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: 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

• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram
• Weight: 250 Milligram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857072005422 [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: 2022-12-01
• Device Publish Date: 2022-11-23

On-Brand Devices [Miro3D® Fibers]

• 00857072005446: Wound matrix
• 00857072005439: Wound matrix
• 00857072005422: Wound matrix
• 00857072005415: Wound matrix