MiroDerm Fenestrated

GUDID 00857072005170

4 x 4 cm Fenestrated Biologic Wound Matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing

• Primary Device ID: 00857072005170
• NIH Device Record Key: 637e0794-c6bb-4fac-8af5-d55f539abce0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiroDerm Fenestrated
• Version Model Number: BLM-200-02-0404
• 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	00857072005170 [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