Anthem Wound Matrix Fenestrated AN-0035

GUDID 00852513007270

NANOFIBER SOLUTIONS, INC.

Synthetic nanofiber barrier dressing

• Primary Device ID: 00852513007270
• NIH Device Record Key: 18af96bc-1f22-4c07-927a-34f5aa8d33e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anthem Wound Matrix Fenestrated
• Version Model Number: FG-0035
• Catalog Number: AN-0035
• 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	00852513007270 [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