Rotium Bioresorbable Wick

GUDID 00852513007317

NANOFIBER SOLUTIONS, INC.

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• Primary Device ID: 00852513007317
• NIH Device Record Key: 9528218b-0b1f-4c59-9865-90286021febe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotium Bioresorbable Wick
• Version Model Number: FG-0043
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852513007317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201414

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2022-10-26
• Device Publish Date: 2022-10-18

On-Brand Devices [Rotium Bioresorbable Wick]

• 20852513007052: FG-0007
• 00852513007317: FG-0043