Durolane

GUDID 05065026658005

MAPLESTONE DEVELOPMENTS LIMITED

Synovial fluid supplementation medium

• Primary Device ID: 05065026658005
• NIH Device Record Key: 33d48c78-ef3e-4004-9ce9-ce0c1d08d8d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durolane
• Version Model Number: N/A
• Company DUNS: 225683605
• Company Name: MAPLESTONE DEVELOPMENTS 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065026658005 [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: 2026-03-12
• Device Publish Date: 2026-03-04

Devices Manufactured by MAPLESTONE DEVELOPMENTS LIMITED

• 05065026658005 - Durolane: 2026-03-12
• 05065026658005 - Durolane: 2026-03-12
• 05065026658067 - Euflexxa: 2026-03-12
• 05065026658029 - Monovisc: 2026-03-12
• 05065026658036 - Orthovisc: 2026-03-12
• 05065026658043 - Synvisc: 2026-03-12
• 05065026658074 - Synvisc: 2026-03-12