Anthem Wound Matrix Fenestrated AN-0031

GUDID 00852513007232

NANOFIBER SOLUTIONS, INC.

Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing Synthetic nanofiber barrier dressing

• Primary Device ID: 00852513007232
• NIH Device Record Key: 9ea216ca-e79e-49a2-9869-79bbd259770c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anthem Wound Matrix Fenestrated
• Version Model Number: FG-0031
• Catalog Number: AN-0031
• Company DUNS: 830384223
• Company Name: NANOFIBER SOLUTIONS, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852513007232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173544

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: 2021-05-11
• Device Publish Date: 2021-05-03

On-Brand Devices [Anthem Wound Matrix Fenestrated]

• 00852513007300: FG-0038
• 00852513007294: FG-0037
• 00852513007287: FG-0036
• 00852513007270: FG-0035
• 00852513007263: FG-0034
• 00852513007256: FG-0033
• 00852513007249: FG-0032
• 00852513007232: FG-0031