Rotium

GUDID 00852513007447

NANOFIBER SOLUTIONS, INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 00852513007447
• NIH Device Record Key: c89ff59d-0e1a-45ed-953e-74d42f152ef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotium
• Version Model Number: FG-0220
• 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	00852513007447 [Primary]

FDA Product Code

• OWW: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

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: 2025-04-25
• Device Publish Date: 2025-04-17

On-Brand Devices [Rotium]

• 00852513007492: FG-0725
• 00852513007485: FG-0630
• 00852513007478: FG-0525
• 00852513007461: FG-0430
• 00852513007454: FG-0325
• 00852513007447: FG-0220