Synvisc One

GUDID 05060604130034

Inject into the knee to relieve the pain from osteoarthritis.

ACRE PHARMA LIMITED

Synovial fluid supplementation medium

• Primary Device ID: 05060604130034
• NIH Device Record Key: 68b6820a-cd06-407a-8d55-c9dcf6f7f686
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synvisc One
• Version Model Number: NA
• Company DUNS: 218668297
• Company Name: ACRE PHARMA LIMITED
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060604130034 [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: 2018-07-27
• Device Publish Date: 2018-04-27

Devices Manufactured by ACRE PHARMA LIMITED

• 05060604130065 - Monovisc: 2019-02-14
• 05060604130041 - Synvisc: 2018-08-27
• 05060604130034 - Synvisc One: 2018-07-27Inject into the knee to relieve the pain from osteoarthritis.
• 05060604130034 - Synvisc One: 2018-07-27 Inject into the knee to relieve the pain from osteoarthritis.
• 05060604130003 - Euflexxa: 2018-05-28 Injected into the knee to relieve the pain from osteoarthritis.
• 05060604130010 - Orthovisc: 2018-05-28 Inject into the knee to relieve the pain caused by osteoarthritis.
• 05060604130027 - Supartz: 2018-05-28 Injected into the knee to relieve the pain from osteoarthritis.