HYALGAN

GUDID 35060432190003

injectable (hyaluronic acid, intra-articular)

FCL HEALTH SOLUTIONS LTD

Synovial fluid supplementation medium Synovial fluid supplementation medium

• Primary Device ID: 35060432190003
• NIH Device Record Key: 65fe0f36-fa49-4113-b7e1-115af0e9d347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYALGAN
• Version Model Number: None
• Company DUNS: 219706976
• Company Name: FCL HEALTH SOLUTIONS LTD
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: info@fclhealth.com
• Phone: 999-999-9999
• Email: info@fclhealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	35060432190003 [Primary]

FDA Product Code

• MOZ: Acid, Hyaluronic, Intraarticular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-05-26

Devices Manufactured by FCL HEALTH SOLUTIONS LTD

• 15060432190009 - SYNVISC ONE: 2018-03-29 Acid, Hyaluronic, Intraarticular
• 65060432190004 - SYNVISC: 2018-03-29 injectable (hyaluronic acid, intra-articular)
• 35060432190003 - HYALGAN: 2018-03-29injectable (hyaluronic acid, intra-articular)
• 35060432190003 - HYALGAN: 2018-03-29 injectable (hyaluronic acid, intra-articular)
• 45060432190000 - Euflexxa: 2018-03-29
• 75060432190001 - Orthovisc: 2018-03-29
• 05060432190019 - Supartz: 2018-03-29
• 05060432190026 - Monovisc: 2018-03-29
• 05060432190033 - Radiesse: 2018-03-29