BIOCHARGE BC-2012

GUDID 00852513007355

NANOFIBER SOLUTIONS, INC.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00852513007355
• NIH Device Record Key: a992b727-e977-475d-b161-e17f62ae3db4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCHARGE
• Version Model Number: FG-2012
• Catalog Number: BC-2012
• 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	00852513007355 [Primary]
GS1	10852513007352 [Package]; Package: [2 Units]; In Commercial Distribution

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: 2024-10-03
• Device Publish Date: 2024-09-25

Devices Manufactured by NANOFIBER SOLUTIONS, INC.

• 00852513007393 - Phoenix Surgical Wound Matrix Fenestrated: 2025-04-25
• 00852513007409 - Phoenix Surgical Wound Matrix Fenestrated: 2025-04-25
• 00852513007416 - Phoenix Surgical Wound Matrix Fenestrated: 2025-04-25
• 00852513007423 - Phoenix Surgical Wound Matrix Fenestrated: 2025-04-25
• 00852513007430 - Phoenix Surgical Wound Matrix Fenestrated: 2025-04-25
• 00852513007447 - Rotium: 2025-04-25
• 00852513007454 - Rotium: 2025-04-25
• 00852513007461 - Rotium: 2025-04-25