SYNVISC

GUDID 65060432190004

injectable (hyaluronic acid, intra-articular)

FCL HEALTH SOLUTIONS LTD

Synovial fluid supplementation medium

• Primary Device ID: 65060432190004
• NIH Device Record Key: 6f1100c4-7038-41a1-9a0a-b0519554b1c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNVISC
• Version Model Number: HYLAN GF-20
• Company DUNS: 219706976
• Company Name: FCL HEALTH SOLUTIONS LTD
• Device Count: 3
• 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: 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	05060432190002 [Unit of Use]
GS1	25060432190006 [Primary]
GS1	65060432190004 [Package]; Contains: 25060432190006; Package: [3 Units]; In Commercial Distribution

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: 2018-03-29injectable (hyaluronic acid, intra-articular)
• 65060432190004 - SYNVISC: 2018-03-29 injectable (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