Durolane

GUDID 05060548950071

PAVAN TRADING LTD

Synovial fluid supplementation medium

• Primary Device ID: 05060548950071
• NIH Device Record Key: e23e36f6-a253-4851-94cc-63f9e2e29c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durolane
• Version Model Number: N/A
• Company DUNS: 216985640
• Company Name: PAVAN TRADING 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: true
• Manufacturing Date: true
• 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 8 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060548950071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170007

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: 2019-01-07
• Device Publish Date: 2018-12-06

Devices Manufactured by PAVAN TRADING LTD

• 05060548950071 - Durolane: 2019-01-07
• 05060548950071 - Durolane: 2019-01-07
• 05060548950019 - Synvisc One (Synvisc Three): 2018-07-19 Synvisc is injected into the knee to alleviate the pain of osteoarthritis.
• 05060548950026 - Orthovisc: 2018-07-19 Orthovisc is injected into the knee joint to cushion and lubricate.
• 05060548950033 - Monovisc: 2018-07-19 Monovisc is injected into the knee to relieve the pain of osteoarthritis.
• 05060548950057 - Supartz: 2018-07-19 Supartz is injected into the knee to relieve the pain of osteoarthritis.
• 05060548950064 - Euflexxa: 2018-07-19 Euflexxa is injected into the knee to relieve the pain of osteoarthritis.