TriLURON 89122-0879-01

GUDID M71389122087901A1

TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL

FIDIA FARMACEUTICI SPA

Synovial fluid supplementation medium

• Primary Device ID: M71389122087901A1
• NIH Device Record Key: dc996787-66d3-40d8-a3c9-0ed1eea38507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriLURON
• Version Model Number: M71389122087901A13
• Catalog Number: 89122-0879-01
• Company DUNS: 428453013
• Company Name: FIDIA FARMACEUTICI SPA
• 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

Customer Support Contacts

• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us
• Phone: 866-749-2542
• Email: compliance@fidiapharma.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71389122087901A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P180040

FDA Product Code

• MOZ: Acid, Hyaluronic, Intraarticular

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [TriLURON]

• M71389122087901SAM1: TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL - Professional Sample -
• M71389122087901A1: TriLURON (sodium hyaluronate) 1 prefilled syringe - 2 mL, 20mg per 2 mL