MiroDerm Fenestrated

GUDID 00857072005125

5 x 5 cm Fenestrated Biologic 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 Collagen wound matrix dressing

• Primary Device ID: 00857072005125
• NIH Device Record Key: c71c6fae-919e-43cb-b73a-42bd14dcd338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiroDerm Fenestrated
• Version Model Number: BLM-200-02-0505
• 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
• Phone: 952-377-8238
• Email: customerservice@reprisebio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857072005125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143426

FDA Product Code

• KGN: Dressing, Wound, Collagen

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [MiroDerm Fenestrated]

• 00857072005309: 2x2 cm Fenestrated Biologic Wound Matrix
• 00857072005293: 2x3 cm Fenestrated Biologic Wound Matrix
• 00857072005170: 4 x 4 cm Fenestrated Biologic Wound Matrix
• 00857072005163: 3 x 3 cm Fenestrated Biologic Wound Matrix
• 00857072005156: 8 x 15 cm Fenestrated Biologic Wound Matrix
• 00857072005149: 7 x 10 cm Fenestrated Biologic Wound Matrix
• 00857072005132: 8 x 8 cm Fenestrated Biologic Wound Matrix
• 00857072005125: 5 x 5 cm Fenestrated Biologic Wound Matrix
• 00857072005118: 3 x 7 cm Fenestrated Biologic Wound Matrix